Regular Telephone Contact Research Articles

Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial

BackgroundPhysical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients’ compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients.ObjectivesThe WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients.MethodsThe WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period.DiscussionThe trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients’ recruitment and impacted their physical activity patterns.ConclusionsThe present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results.Trial registrationClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).

Frequency of cast-related complications and influencing factors in patients with casts

BackgroundCasting is a common procedure in the treatment of extremity fractures, but it can lead to serious complications if applied improperly. However, there are few studies on the prevalence of cast-related complications. PurposeTo assess the frequency of cast-related complications and influencing factors in patients referred to medical centers affiliated with a University of Medical Sciences. MethodsA descriptive study was conducted on 120 patients with limb fractures in need of casting. The study was conducted from November 1, 2020, to June 1, 2021. A checklist was used to assess complications, and complications were monitored by regular telephone contact. Each patient was followed up for 3 months. Descriptive and inferential statistics were used to analyze the data. ResultsPain, impaired mobility, numbness, swelling, and a burning sensation inside the cast were the most common complications in the first week after cast application and occurred in 94.2%, 72.5%, 60.8%, 60%, and 54.2% of patients, respectively. Patients whose casts were applied by a nurse experienced more pain (p = 0.002), numbness (p = 0.02), and swelling (p = 0.05). The incidence of numbness was significantly higher in patients who were more active during convalescence (p = 0.04). ConclusionsDue to the importance of cast-related complications, in-service training programs for casting staff are needed. Furthermore, patient education and follow-up should be taken more seriously.

The Effectiveness of the Transitional Care Program Among People Awaiting Coronary Artery Bypass Graft Surgery: A Randomized Control Trial.

This study examined the effectiveness of the Transitional Care Program (TCP) on the anxiety, depression, cardiac self-efficacy, number of hospitalizations, and satisfaction with care among people awaiting elective coronary artery bypass graft (CABG) surgery. The study design was a randomized controlled trial. The participants with coronary artery disease who met the study criteria (n = 104) were randomly assigned to the intervention group (n = 52) receiving the TCP plus routine care, or the control group (n = 52) receiving routine care only. The TCP, developed based on the Transitional Care Model, comprised hospital discharge planning and six weekly home telephone follow-ups to provide health education, counseling, monitoring, and emotional support tailored to the individual's needs. Data were collected at baseline, and then at weeks 1, 6, and 8 after program enrollment. Data were analyzed using descriptive statistics, repeated-measures analysis of variance, and the Z test. The intervention group had lower anxiety and depression than did the control group at weeks 1, 6, and 8 after program enrollment. At weeks 6 and 8, the intervention group exhibited higher cardiac self-efficacy and satisfaction with care than the control group. Further, the intervention group had a significantly lower number of hospitalizations than the control group at week 8. The TCP can reduce anxiety, depression, and number of hospitalizations, while increasing cardiac self-efficacy and satisfaction with care among people awaiting CABG. Nurses are in a pivotal position to make care transitions safer. Provision of discharge education and regular telephone contacts could enhance positive outcomes regarding patients awaiting elective cardiac surgery.

Exploring patient experiences of participating in a telephone-based self-management support intervention: Proactive Health Support (PaHS).

Proactive Health Support is a telephone-based self-management intervention that is carried out in Denmark by Registered Nurses who provide self-management support to people at risk of hospital admission. We aimed to explore participants' experiences of Proactive Health Support and to identify what the participants find important and meaningful during the intervention process. Qualitative design involving semi-structured interview. Using a phenomenological-hermeneutical framework, we conducted semi-structured interviews with 62 participants in their own homes (32 women, 30 men; aged 20-81years) in spring and fall 2018. The participants felt confident that they could discuss every matter with the nurses. Participants benefitted from accessibility to the nurses' professional and medical competences and they felt relief that the nurses contacted them via the telephone due to their multiple health conditions. The participants felt that the nurses were available and helped them to navigate the healthcare system. The participants valued the intervention because they benefitted from the nurses' holistic approach. They described the nurses' knowledge and professionalism in relation to their symptoms, treatments, and medicine as important and meaningful. Accordingly, the intervention seemed to promote feelings of independence and self-management among the participants. From a nursing perspective, the study highlights that it is possible to establish a close relationship and behavioural change among participants through regular telephone contact.

Older people living alone (OPLA) \u2013 non-kin-carers\u2019 support towards the end of life: qualitative longitudinal study protocol

BackgroundA growing number of older people, mainly women, live in single households. They represent a vulnerable group as staying at home may turn out challenging when care needs increase, particularly at the end of life. Non-kin-carers can play an essential role in supporting individuals’ preferences to stay at home. In research little attention has been paid to non-kin-carers, such as friends and neighbors, yet. Thus, the Older People Living Alone (OPLA) study will evaluate whether non-kin support is robust enough to enable care dependent people to stay at home even at the end of life. This paper aims to introduce the research protocol.MethodsWe plan to apply a qualitative longitudinal study to better understand how older people living alone and their non-kin-carers manage to face the challenges with increased care needs towards the end-of-life. We will conduct serial interviews with the older persons living alone and their non-kin-carers. A total of 20–25 complete data sets and up to 200 personal interviews were planned. These will be complemented by regular telephone contacts. All interviews will be analysed following the grounded theory approach and strategies for reconstructing case trajectories, supported by MAXQDA software. In the course of the study, inter- and transdisciplinary workshops shall assure quality and support knowledge transfer.DiscussionThis study protocol aims to guide research in a field that is difficult to approach, with regard to its topic, methodology and the interdisciplinary approach. As this study introduces longitudinal qualitative research methodology in the field of home care in Austria, a deeper understanding of (end-of-life-) care trajectories will be enhanced, which is of major relevance for future care planning. With investment in additional reflexivity and communication procedures innovative results and robust knowledge are expected outcomes.

Effectiveness of a telephone-delivered psycho-behavioural intervention on depression in elderly with chronic heart failure: rationale and design of a randomized controlled trial

BackgroundDepression is common among chronic heart failure (CHF) patients, and it is associated with significant re-hospitalization and mortality as well as lower quality of life. While psychotherapy is efficacious treatment for depression, the effect for depression among CHF is uncertain. And barriers preclude widely utility of psychotherapy among the elderly. Telephone-delivered psycho-behavioural intervention specifically focuses on depression among the elderly with CHF, and could be a promising alternative to conventional treatment. The present study was designed to prospectively investigate the effect of a telephone-delivered psycho-behavioural intervention on depression in the elderly with chronic heart failure (CHF).Method/designIn this prospective, multicentre, parallel, randomized, and controlled trial, 236 participants with depression associated with CHF (New York Heart Association classes II and III) will be enrolled. The study will consist of a 12-week intensive intervention and a 24-week maintenance intervention. Eligible participants will be randomized to either the intervention arm or the control arm. During the intensive phase, participants will receive either a guided telephone psycho-behavioural intervention or regular telephone contacts from the counsellors weekly. During the maintenance phase, participants will receive either psychological behavioural support or regular telephone contacts monthly from counsellors. Depressive symptoms, cardiac outcome and quality of life will be assessed at baseline and weeks 1, 2, 4, 8, 12, 24 and 36. Participants will undergo echocardiography and the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) tested at baseline, weeks 12 and 36. The primary outcome is the response rate of depression, from baseline to week 12. The second outcomes include the change in cardiac function, quality of life and severity of depressive symptoms during the trial.DiscussionTo our knowledge, this study is the first prospective randomized trial to test the effective of the telephone-delivered psycho-behavioural intervention on depression in the elderly with CHF. The findings are expected to provide a new and evidence-based approach for depression among the elderly with CHF.Trial registrationThe trial was registered at www.clinicaltrials.gov (identification number: NCT03233451) on 28 July 2017 and updated on 18 August 2017.

Outcomes of Ambulatory Upper Extremity Surgery Patients Discharged Home with Perineural Catheters from a Veterans Health Administration Medical Center.

The feasibility and safety of managing ambulatory continuous peripheral nerve blocks (CPNB) in Veterans Health Administration (VHA) patients are currently unknown. We aimed to characterize the outcomes of a large VHA cohort of ambulatory upper extremity surgery patients discharged with CPNB and identify differences, if any, between catheter types. With institutional review board approval, we reviewed data for consecutive patients from a single VHA hospital who had received ambulatory CPNB for upper extremity surgery from March 2011 to May 2017. The composite primary outcome was the occurrence of any catheter-related issue or additional all-cause health care intervention after discharge. Our secondary outcome was the ability to achieve regular daily telephone contact. Five hundred one patients formed the final sample. The incidence of any issue or health care intervention was 104/274 (38%) for infraclavicular, 58/185 (31%) for interscalene, and 14/42 (33%) for supraclavicular; these rates did not differ between groups. Higher ASA status was associated with greater odds of having any issue, whereas increasing age was slightly protective. Distance was associated with an increase in catheter-related issues (P < 0.01) but not additional health care interventions (P = 0.51). Only interscalene catheter patients (3%) reported breathing difficulty. Infraclavicular catheter patients had the most emergency room visits but rarely for CPNB issues. Consistent daily telephone contact was not achieved. For VHA ambulatory CPNB patients, the combined incidence of a catheter-related issue or additional health care intervention was approximately one in three patients and did not differ by brachial plexus catheter type. Serious adverse events were generally uncommon.

“A Sure Thing” - Connecting Heart Failure Patients through the inpatient Heart Failure Navigator to the Outpatient Care Coordination Team: A Highly Successful Strategy to Reduce Readmissions

Introduction Heart Failure (HF) readmissions remain a critical issue for health care systems. HF Navigators (HFN) can streamline care transitions. Thus, we used an inpatient HFN to establish early follow up and “hand off” HF pts to an OP Care Coordinator (CC). Methods At our hospital, HF pts can be admitted to multiple IP units. A HF Unit (HFU) primarily admits higher risk pts. A single HFN was recruited to staff the HFU M-F. The HFN linked HF pts to a CC to at discharge. Most HF pts were referred to the OP CC although some pts received only HFN services and no CC due to difficulty identifying HF pts prior to discharge. Over the 14-month period, the HFN established early follow-up and the CC made regular telephone contact post discharge. The incremental contributions of the HFN and CC were evaluated to test the independent impact of each of these roles based on the serial implementation of these roles in distinct hospital units and based on whether or not a particular HF pt was cared for by the HFN and/or the CC. Results Thirty (30) day readmission rates were measured for pts admitted between October 17, 2016 and December 31, 2017. Patients with a primary, discharge diagnosis of HF were analyzed. HFN services were provided on the dedicated HF unit (HFU) as part of a pilot program and were not available on other IP units during this period. Concurrent 30-day all-cause readmission data were stratified and reported based on admitting unit, involvement of the HFN with or without CC. Of the 757 pts (non LVAD or Transplant) who were admitted to units other than the HFU, there were 160 pts readmitted (21.1%). There were 254 high risk (Includes LVAD and transplant pts) HF pts admitted to the HFU, and there were 75 pts readmitted (29.5%) in this cohort. There were 33 (non LVAD or transplant) pts admitted to the HFU with care provided by HFN but who did not receive a referral to CC, and 6 pts were readmitted (18.9%). Finally, of the 169 HF pts were admitted to the HFU and had access to a HFN and CC, with only 9 pts readmitted (5.33%). Conclusions In this analysis, there was a synergistic effect noted to drastically reduce HF readmission rates when an IP HFN and OP CC were involved in the care of hospitalized HF pts. The 5.33% 30 day all cause readmission rates noted is significantly better than rates reported in the literature and reflects the critical role of combining HFN care with care coordination in the OP setting. These data have solidified an interest to expand access to HFN and CC to all IP units and can serve as a model for care delivery to improve readmission rates for this high-risk population.

Telemedical monitoring of patients with chronic heart failure has a positive effect on total health costs

BackgroundTelemedical programs for patients with chronic heart failure have shown inconsistent effects on survival and hospitalization. Few studies analyzed effects of telemedical interventions on health costs, although this outcome may determine whether or not a successful program will be adopted by health insurance providers. We evaluated a large sized telemedicine program provided by a German statutory health insurance, consisting of regular telephone contacts and, for a subgroup of the participants, provision of an electronic scale in a routine care setting. We examined the effects of the program on the total healthcare costs after one year compared to a matched control group.MethodsThe evaluation was based on reimbursement data of the statutory health insurance. Participants of the program were matched to appropriate controls using a combination of exact (e.g. 5-year age group, gender, NYHA class) and propensity score (e.g. medication, psychiatric comorbidity) matching.The total health costs after one year were calculated on the basis of regression analyses in an intention-to-treat-approach. In a sensitivity analysis, the subgroup of patients with a documented beginning of the intervention was examined.ResultsTwo thousand six hundred twenty two patients with chronic heart failure (55% male, mean age: 73.7 years) were included in the intervention program. 1943 participants (74%) could be matched with appropriate control patients. The telemedicine monitoring program for patients with chronic heart failure reduced total health costs after 12 months of the intervention: − 276€ per quarter year in rural regions and − 18€ in urban regions compared to the control group.ConclusionsThe telemedicine program could reduce total health costs, especially in rural regions in Germany.

Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers \u2013 an interventional randomized controlled multicenter trial (LIBRE-1)

BackgroundWomen with pathogenic BRCA germline mutations have an increased risk for breast and ovarian cancer that seems to be modified by life-style factors. Though, randomized trials investigating the impact of lifestyle interventions on cancer prevention and prognosis in BRCA carriers are still missing.MethodsWe implemented a multicenter, prospective randomized controlled trial in BRCA1/2 patients, comparing a lifestyle intervention group (IG) with a control group (CG) with the primary aim to prove feasibility. Intervention comprised a structured, individualized endurance training alongside nutrition education based on the Mediterranean diet (MD) for 3 months, plus monthly group training and regular telephone contact during the subsequent 9 months. The CG attended one session on healthy nutrition and the benefits of physical activity. Primary endpoints were feasibility, acceptance and satisfaction over 12 months. Furthermore, effects on physical fitness, diet profile, body mass index (BMI), quality of life and perceived stress were investigated.ResultsSixty-eight participants (mean age 41, mean BMI 23.2 kg/m2) were enrolled, of whom 55 (81%, 26 IG, 29 CG) completed 12 months. 73% (n = 26) participated in at least 70% of all intervention sessions. Predictors for drop-outs (19%; n = 13) or non-adherence (27%; n = 7) were not found. 73% rated the program highly and 80% would participate again. Severe adverse events did not occur. Positive effects in the IG compared to the CG were observed for secondary endpoints: BMI, MD eating pattern and stress levels.ConclusionsThis lifestyle intervention was feasible, safe and well accepted. Positive results on eating habits, physical fitness and stress levels warrant a larger randomized trial.Trial registrationThe study has been retrospectively registered at ClinicalTrials.gov (reference: NCT02087592) on March 12, 2014. The first patient was included on February 24, 2014.

Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial

BackgroundThe existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE.MethodsOne hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30–60 minutes’ duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. At the time of inclusion, after 2 months, and after 6 months, the patients’ physical capacity is measured using the Incremental Shuttle Walk test. Furthermore the patients’ quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility.DiscussionWe expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of PE patients, and may thereby form the basis of future recommendations in this field.Trial registrationClinicalTrials.gov, NCT02684721. Registered on 20 January 2016.

Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study).

BackgroundWomen with highly penetrant BRCA mutations have a 55–60% lifetime risk for breast cancer and a 16–59% lifetime risk for ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. These include lifestyle factors such as physical activity status, dietary habits, and body weight. The modification of penetrance by changing lifestyle factors has not thus far been investigated in a randomized trial in BRCA mutation carriers.MethodsTherefore, we intend to enroll 60 BRCA1/2 mutation carriers in a pilot feasibility study (Lifestyle Intervention Study in Women with Hereditary Breast and Ovarian Cancer (LIBRE) pilot). This multi-center, prospective, controlled trial aims to randomize (1:1) participants into a (1) multi-factorial lifestyle intervention group (IG) versus (2) the control group with usual care (CG). The primary endpoint is feasibility and acceptance of a structured interdisciplinary lifestyle intervention program over 12 months (at least 70% of the patients to complete the 1-year intervention). Furthermore, the effects on physical fitness, BMI, quality of life, and stress coping capacity will be investigated.During the first 3 months, women in the IG will receive structured, individualized and mainly supervised endurance training of ≥18 MET*h/week (MET = metabolic equivalent task) and personal nutritional counseling based on the Mediterranean diet. During the subsequent 9 months, the IG will receive monthly group training sessions and regular telephone contacts for motivation, whereas the CG will only receive usual care (one general counseling on healthy nutrition and benefits of regular physical activity on health status). At randomization and subsequent time points (3, 6, 12 months), cardiopulmonary fitness will be assessed by spiroergometry and nutritional and psychological status by validated questionnaires.DiscussionThis pilot study will investigate the optimal strategy to improve physical fitness, nutritional habits, and psychological factors in women at high risk for developing breast or ovarian cancer. The results of this pilot feasibility study will be the basis for a larger prospective randomized trial including clinical events (LIBRE).Trial registrationClinicalTrials.gov, NCT02087592

Liver.

Introduction: Cirrhosis patients have reduced peak aerobic power (peak VO2) that is associated with reduced survival. Supervised endurance training is an effective therapy to increase exercise tolerance in cirrhosis. Many patients have challenges coming in regularly for supervised training. The effect of home-based endurance exercise training (HET) on improving on peak VO2 in cirrhosis patients has not been studied. The aim of this pilot study was to evaluate the safety and efficacy of 8 weeks of HET on peak VO2, aerobic endurance (6-minute walk distance), thigh muscle thickness (2D ultrasound) and circumference, and quality of life. Methods: Clinically stable patients with cirrhosis were randomly assigned to 8 weeks of HET (n=20) or usual care (controls, n=20). The HET group performed moderate to high intensity (heart rate equal to 60-80% peak VO2) cycle exercise for 3 days per week. An exercise specialist supervised an HET session once every two weeks and had regular telephone contact between these sessions. Paired t-test was used for within group comparisons and analysis of covariance was used to perform between group comparisons. Results: The cohort (n=40) was 58% male, had a mean age of 57±8 years, and 70% and 30% had Child Pugh class A and B cirrhosis, respectively. The between group VO2 difference trended to significance (P=0.09) and the between group 6-minute walk test increased (Table 1). When within group differences were considered, the HET group had a significant increase in peak VO2 from baseline (17.3±4.5 to 19.0±6.4 mL/kg/min, P=0.03). The 6-minute walk test distance trended to significance (from 476.0±89.8 to 490.7±104.1 meters, P=0.08). There was also a significant increase in the thigh circumference (50.6±5.8 to 52.4±6.6, P=0.02) and thigh muscle thickness (1.25 ±0.40 to 1.31 ±0.38 cm/m2, P=0.05). There was no significant difference in quality of life and no adverse events occurred during cardiopulmonary exercise testing or HET.Table 1: Pilot results from an 8 week, home-based exercise program compared to usual care (control) for patients with cirrhosisConclusion: The 8 weeks of HET is a safe and effective intervention that results in a clinically meaningful improvement in peak VO2, aerobic endurance distance, and increases thigh muscle mass in clinically stable patients with cirrhosis. Clinicaltrials.gov number, NCT02267421. Funded by an ACG Clinical Research Award.

Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial.

BackgroundWomen with highly penetrant BRCA mutations have a 55–60 % lifetime risk for breast cancer and a 16–59 % lifetime risk of developing ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. It is well documented that the risk for sporadic breast cancer disease can be modified by changing lifestyle factors that primarily include physical activity, dietary habits, and body weight. It can thus be hypothesized that the modification of these lifestyle factors may also influence the incidence and progression of cancer in BRCA mutation carriers.Methods/designThis multicenter, interdisciplinary, prospective, two-armed, randomized (1:1) controlled trial aims to enroll a minimum of 600 BRCA1 and BRCA2 mutation carriers to partake in either a lifestyle intervention or usual care. The study primarily aims to demonstrate an improvement of nutritional behavior (adherence to the Mediterranean diet), body mass index, and physical fitness. Furthermore, the effects on quality of life, stress coping capacity, breast cancer incidence, and mortality will be investigated. The intervention group (IG) will receive a structured lifestyle intervention over 12 months, whereas the control group (CG) will only receive information regarding a healthy lifestyle. During the first 3 months, women in the IG will receive structured, individualized, and mainly supervised endurance training with a minimum of 18 MET-h physical activity per week and nutrition education based on the Mediterranean diet. Over the following 9 months, IG monthly group training sessions and regular telephone contacts will motivate study participants. The CG will receive one general training session about healthy nutrition in accordance with the recommendations of the German Society of Nutrition (standard of care in Germany) and the benefits of regular physical activity on health status. At randomization and subsequent time points (3 and 12 months), cardiopulmonary fitness will be assessed by spiroergometry, and nutritional and psychological status will be assessed by validated questionnaires, interviews, and clinical examinations.DiscussionAs data on the role of lifestyle intervention in women with a hereditary risk for breast and ovarian cancer are currently lacking, this study will be of major importance from a scientific, as well as a practical advice viewpoint. It will investigate the optimal strategy to improve physical fitness, nutritional status, and psychological factors such as quality of life, perceived stress, optimism, as well as incidence and outcome of cancer in this selected group of women at high risk. If the study indicates a positive long-term outcome, a structured lifestyle intervention program could be added to health care prevention strategies for BRCA1 and BRCA2 mutation carriers.Trial registrationClinicalTrials.gov: NCT02516540. Registered on 22 July 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1504-0) contains supplementary material, which is available to authorized users.

A pilot randomised trial of community-based care following discharge from hospital with a recent spinal cord injury in Bangladesh

Objectives: To explore the feasibility of conducting a full trial designed to determine the effectiveness of a model of community-based care for people with spinal cord injury in Bangladesh. Study Design: A pilot randomised trial. Setting: Community, Bangladesh. Subjects: Participants were 30 people with recent spinal cord injury who were wheelchair-dependent and soon to be discharged from hospital. Intervention: Participants randomised to the intervention group received a package of care involving regular telephone contact and three home visits over two years. Participants randomised to the control group received usual care consisting of a telephone call and an optional home visit. Main measures: Participants were assessed at baseline and two years after randomization. The primary outcome was mortality and secondary outcomes were measures of complications, depression, participation and quality of life. Results: A total of 24 participants had a complete spinal cord injury and six participants had an incomplete spinal cord injury. Median (interquartile) age and time since injury at baseline were 31 years (24 to 36) and 7 months (4 to 13), respectively. Two participants, one in each group, died. Five participants had pressure ulcers at two years. There were no notable impediments to the conduct of the trial and no significant protocol violations. The phone calls and home visits were delivered according to the protocol 87% and 100% of the time, respectively. Follow-up data were 99% complete. Conclusion: This pilot trial demonstrates the feasibility of a full clinical trial of 410 participants, which has recently commenced. Sponsorship: University of Sydney, Australia.

Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial.

This study aimed to determine whether a self-management support service was more effective than treatment as usual in reducing depressive symptoms and major depressive episodes and increasing personal recovery among individuals with chronic or recurrent depressive symptoms. The study was a randomized controlled trial of a self-management support service consisting of depression self-management training, recovery coaching, and care coordination. The 18-month intervention included regular telephone or in-person contacts with a care manager and a structured group program co-led by a professional therapist and a trained peer specialist. Intervention (N=150) and control (N=152) participants ages ≥ 18 with chronic or recurrent depressive symptoms were recruited from five clinics in Seattle, Washington. Outcome measures included the Hopkins Symptom Checklist depression scale, the Recovery Assessment Scale, the Patient-Rated Global Improvement scale, and the percentage of participants with a major depressive episode. Interviewers were masked to treatment condition. Repeated-measures estimates of the long-term effect of the intervention versus usual care (average of the six-, 12-, and 18-month outcomes adjusted for age, gender, and site) indicated that intervention participants had less severe symptoms (p=.002) and higher recovery scores (p=.03), were less likely to be depressed (odds ratio [OR]=.52, p=.001), and were more likely to be much improved (OR=1.96, p=.001). These findings support providing regular outreach care management and a self-care group offering a combined behavioral and recovery-oriented approach for people with chronic or recurrent depressive symptoms.

Bridging the gap between medical settings and specialty addiction treatment.

Keywords: Alcohol misuse; care linkage; medical settings; specialty addiction treatment

Methodological developments in qualitative longitudinal research: the advantages and challenges of regular telephone contact with participants in a qualitative longitudinal interview study.

BackgroundQualitative longitudinal research is an evolving methodology, particularly within health care research. It facilitates a nuanced understanding of how phenomena change over time and is ripe for innovative approaches. However, methodological reflections which are tailored to health care research are scarce. This article provides a synthesised and practical account of the advantages and challenges of maintaining regular telephone contact between interviews with participants in a qualitative longitudinal study.MethodsParticipants with metastatic colorectal cancer were interviewed at 3 time points over the course of a year. Half the group also received monthly telephone calls to explore the added value and the feasibility of capturing change as close to when it was occurring as possible.ResultsThe data gathered from the telephone calls added context to the participants’ overall narrative and informed subsequent interviews. The telephone calls meant we were able to capture change close to when it happened and there was a more evolved, and involved, relationship between the researcher and the participants who were called on a monthly basis. However, ethical challenges were amplified, boundaries of the participant/researcher relationship questioned, and there was the added analytical burden.ConclusionsThe telephone calls facilitated a more nuanced understanding of the illness experience to emerge, when compared with the interview only group. The findings suggest that intensive telephone contact may be justified if retention is an issue, when the phenomena being studied is unpredictable and when participants feel disempowered or lack control. These are potential issues for research involving participants with long-term illness.

Case management via telephone counseling and SMS for weight maintenance in adolescent obesity: study concept of the TeAM program.

BackgroundIn-patient obesity treatment programs for adolescents are associated with good success and substantial weight loss. However, maintaining weight loss remains a challenge. This article presents the concept of the TeAM (Telephone counseling as Adiposity Management) program. TeAM is an innovative, weight maintenance program for obese adolescents after in-patient therapy. It applies the case management approach in combination with new media (telephone counseling, web forum, and SMS messaging). Adolescents (14–18 years) were recruited via German rehabilitation hospitals. The intervention of the TeAM program consists of telephone counseling through trained case managers in order to maintain body weight reduction (expressed as BMI-SDS: body mass index standard deviation score) achieved during an in-patient obesity therapy. At baseline and after completion of the program, participants provide anthropometric measures (obtained by trained medical staff) as well as information on socio-demographics, usage of health services, psychosocial status, daily physical activity, media consumption, and eating behavior. The core of the intervention is regular telephone contact with the adolescent participants combined with tailored SMS messages. Telephone counseling is based on the systemic approach and addresses the topics of mental hygiene, physical activity, sedentary behavior, diet and eating behavior.ResultsBaseline data of the feasibility study: Thirty-eight adolescents were recruited for the feasibility study (14 male, 24 female; mean age 15.82 years); out of them, ten participants lived with a single parent; 68% planned to graduate from school without pre-requisites for university admission (O-level). The mean weight loss during in-patient treatment was 0.32 BMI-SDS units. Mean BMI at the start of intervention was 31.93 kg/m2, corresponding to a mean BMI-SDS of 2.48.ConclusionsWeight maintenance treatment programs for adolescent obesity utilizing new media are a promising approach as they reach adolescents directly within their everyday life.Trial registrationDRKS00004583.

Diabetes increases short- and long-term mortality after transcatheter aortic valve implantation (TAVI)

Long-term mortality after transcatheter aortic valve implantation (TAVI) in elderly patients with abundant comorbidities is considerable. We aimed to determine the impact of diabetes on short- and long-term mortality after TAVI. Our study includes 300 consecutive patients (mean age, 82 ± 5 years) who underwent TAVI (158 transapical, 142 transfemoral procedures). All patients were followed by regular telephone contacts. 36% suffered from diabetes. Diabetes could be identified as significant predictor of short- and long-term mortality after TAVI. In diabetic patients, 30-day-mortality was 2,5 fold elevated (18.3% vs. 7.3%, p = 0.004). Furthermore, they were at significantly higher risk of peri-interventional stroke (p = 0.04), stage 3 acute kidney injury (p = 0.003), and prolonged ventilation (p = 0.01). Even after successful TAVI and discharge from hospital, long-term mortality was significantly elevated in diabetic patients (56% vs. 30%, p < 0.0001). Of note, 25% of diabetic vs. only 8% of non-diabetic patients died from cardiac causes during follow-up, suggesting that TAVI is not able to reduce cardiac-related mortality risk in diabetic patients to the same extent as in non-diabetics. Diabetes represents a powerful predictor of adverse early and late outcome after TAVI. These findings should be incorporated into the assessment of the risk-to-benefit ratio of TAVI in diabetic patients.