Information-only Control Group Research Articles

0822 Sleep and Nighttime Urine Production

Abstract Introduction Nocturia (waking from sleep to urinate) is the most common cause of sleep interruption among older adults and nocturnal polyuria (NP; increased sleep time urine production) is its most common cause. Conversely, poor sleep with repeated awakenings contributes to both nocturia and NP. However, whether a behavioral intervention to reduce repeated awakenings can improve nocturia and NP has not been examined in a clinical trial. The current study assesses the effect of Brief Behavioral Treatment for Insomnia (BBTI) on nocturia and NP in older adults. Methods Fifty-six community-dwelling older adults (mean age, 72±6 years; 64% women) with nocturia frequency ≥2 per night were randomized to receive BBTI vs information-only control (IC). All participants completed a 3-day voiding and sleep diary to assess nocturia, and sleep. Participants with a nocturnal polyuria index (NPi; percent of 24-hour urine volume excreted at night) ≥35% were considered to have NP. Results At baseline, nocturia frequency correlated with total sleep time (r=.54, p< 0.001) and duration of the first uninterrupted sleep period (FUSP, r=-.40, p=0.004) after adjusting for age and body mass index. BBTI significantly improved nocturia frequency compared to the IC group (-1.0±0.7 vs -0.3±0.9; p=.02). FUSP increased by 54±77 minutes in the BBTI group and NPi decreased by 7.1±13.2%, but these changes were not significantly different from the IC group. Change in NPi correlated with change in FUSP (r=-.36, p=.01; longer FUSP associated with lower NPi), but not with change in total sleep time (r=-.04, p=.7). Conclusion In older adults with nocturia, behavioral treatment directed solely at sleep also improves nocturia. Improving sleep continuity in the first half of the night and increasing FUSP, but not total sleep time, may also improve NP. Support (if any) NIA AG060292

0344 Behavioral Treatment of Insomnia with Concurrent Nocturia

Abstract Introduction Behavioral therapy has proved effective for insomnia in older adults. However, its efficacy has not been examined among those with nocturia (awakening to urinate) which is the most common cause of insomnia in this age group. Thus we assessed the impact of behavioral sleep treatment on sleep in older adults with nocturia. Methods Fifty-six community-dwelling older adults (mean age, 72±6 years; 64% women) with nocturia frequency ≥2 per night were randomized to receive Brief Behavioral Treatment for Insomnia (BBTI) or information-only control (IC). We determined the impact of BBTI on sleep, sleep quality, and nocturia as assessed by a 3-day voiding and sleep diary. Participants concurrently wore a single-channel, EEG device Z-machine® for objective in-home sleep assessment. Insomnia Severity Index (ISI) was used to assess insomnia symptoms. Results Participants had a mean nocturia frequency of 2.2±0.7/night at baseline. Time in bed (TIB) decreased by 42±76 minutes among the BBTI group, but total sleep time (TST) increased by 20±95. Significant differences ± standard error between BBTI and IC in pre- to post-intervention changes were observed for TIB (-41±18 minutes, p=.03) but not TST (27±18, p=.14). Compared to the IC group, the BBTI group also showed a greater improvement in ISI (-3.3±1.4, p=.02) as well as objectively measured sleep onset latency (-9.8±3.5, p=.008), latency to deep sleep (-19±11, p=.08), and percentage of total sleep time spent in deep sleep (8.4±3.1, p=.01). BBTI also decreased nocturia frequency to a greater extent (-0.49±0.20, p=.02) Conclusion BBTI improves insomnia symptoms, objective sleep measures, and nocturia in older adults with frequent sleep interruptions related to nocturia. Treatment for insomnia may be an important addition to current treatments for nocturia. Support (if any) NIA AG 060292

“Welcome to your Daily Wellness Check”: The Proposed Evaluation of a SMS-based Conversational Agent for Managing Health and Wellbeing

University students tend to sacrifice healthy lifestyles in favor of academic and financial gain. Additionally, the COVID-19 pandemic has led to online schooling and reduced access to healthcare resources. To mitigate these pressures, artificial intelligence conversational agents (CA) have addressed mental wellness in the general population but are yet to address physical well-being. Therefore, a CA that can address barriers and improve physical and mental well-being by cultivating healthy behaviors is desired. This research is designed to evaluate the feasibility and user experience of a text-based CA on addressing student barriers for a healthy lifestyle using evidence-based theories including the Theory of Planned Behavior and Motivational Interviewing over a two-week timeframe. Data collection has been paused due to the pandemic; results are expected to show positive impacts on well-being outcomes compared to an information-only control group and support the implementation of CAs to those with less accessibility to healthcare resources.

Better Knee, Better Me\u2122: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis \u2013 protocol for a randomized controlled trial

BackgroundAlthough education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese.MethodsThree-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed.DiscussionThis pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).

Using Psychological Artificial Intelligence (Tess) to Relieve Symptoms of Depression and Anxiety: Randomized Controlled Trial.

BackgroundStudents in need of mental health care face many barriers including cost, location, availability, and stigma. Studies show that computer-assisted therapy and 1 conversational chatbot delivering cognitive behavioral therapy (CBT) offer a less-intensive and more cost-effective alternative for treating depression and anxiety. Although CBT is one of the most effective treatment methods, applying an integrative approach has been linked to equally effective posttreatment improvement. Integrative psychological artificial intelligence (AI) offers a scalable solution as the demand for affordable, convenient, lasting, and secure support grows.ObjectiveThis study aimed to assess the feasibility and efficacy of using an integrative psychological AI, Tess, to reduce self-identified symptoms of depression and anxiety in college students.MethodsIn this randomized controlled trial, 75 participants were recruited from 15 universities across the United States. All participants completed Web-based surveys, including the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Positive and Negative Affect Scale (PANAS) at baseline and 2 to 4 weeks later (T2). The 2 test groups consisted of 50 participants in total and were randomized to receive unlimited access to Tess for either 2 weeks (n=24) or 4 weeks (n=26). The information-only control group participants (n=24) received an electronic link to the National Institute of Mental Health’s (NIMH) eBook on depression among college students and were only granted access to Tess after completion of the study.ResultsA sample of 74 participants completed this study with 0% attrition from the test group and less than 1% attrition from the control group (1/24). The average age of participants was 22.9 years, with 70% of participants being female (52/74), mostly Asian (37/74, 51%), and white (32/74, 41%). Group 1 received unlimited access to Tess, with daily check-ins for 2 weeks. Group 2 received unlimited access to Tess with biweekly check-ins for 4 weeks. The information-only control group was provided with an electronic link to the NIMH’s eBook. Multivariate analysis of covariance was conducted. We used an alpha level of .05 for all statistical tests. Results revealed a statistically significant difference between the control group and group 1, such that group 1 reported a significant reduction in symptoms of depression as measured by the PHQ-9 (P=.03), whereas those in the control group did not. A statistically significant difference was found between the control group and both test groups 1 and 2 for symptoms of anxiety as measured by the GAD-7. Group 1 (P=.045) and group 2 (P=.02) reported a significant reduction in symptoms of anxiety, whereas the control group did not. A statistically significant difference was found on the PANAS between the control group and group 1 (P=.03) and suggests that Tess did impact scores.ConclusionsThis study offers evidence that AI can serve as a cost-effective and accessible therapeutic agent. Although not designed to appropriate the role of a trained therapist, integrative psychological AI emerges as a feasible option for delivering support.Trial RegistrationInternational Standard Randomized Controlled Trial Number: ISRCTN61214172; https://doi.org/10.1186/ISRCTN61214172.

Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial

Background: Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). Objective: To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. Methods: A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength – CIS20r) and participation (Impact on Participation and Autonomy scale – IPA). Results: Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = −0.81; 95% confidence interval (CI), −3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). Conclusion: The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

Cost-effectiveness of Wisconsin TEAM model for improving adherence and hypertension control in black patients

ObjectivesTo assess the cost-effectiveness of the 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community pharmacies using prospectively collected cost data. DesignCost-effectiveness analysis of a cluster-randomized trial. SettingTwenty-eight chain pharmacies in 5 Wisconsin cities from December 2006 to February 2009. ParticipantsFive hundred seventy-six black patients with uncontrolled hypertension. InterventionPharmacists and pharmacy technicians using novel tools for improving adherence and feedback to patients and physicians as compared to information-only control group. Main outcome measuresIncremental cost analysis of variable costs from the pharmacy perspective captured prospectively at the participant level. Outcomes (effect measures) were 6-month refill adherence, changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), and proportion of patients achieving blood pressure (BP) control. ResultsMean cost of intervention personnel time and tools was $104.8 ± $45.2. Incremental variable costs per millimeter of mercury decrease in SBP and DBP were $22.2 ± 16.3 and $66.0 ± 228.4, respectively. The cost of helping 1 more person achieve the BP goal (<140/90 mm Hg) was $665.2 ± 265.2; the cost of helping 1 more person achieve good refill adherence was $463.3 ± 110.7. Prescription drug costs were higher for the TEAM group ($392.8 [SD = 396.3] versus $307.0 [SD = 295.2]; P = 0.02). The startup cost for pharmacy furniture, equipment, and privacy screen was $168 per pharmacy. ConclusionOur randomized, practice-based intervention demonstrates that community pharmacists can implement a cost-effective intervention to improve hypertension control in blacks. This approach imposes a nominal expense at the pharmacy level that can be integrated into the ongoing pharmacist-patient relationship, and can enhance clinical and behavioral outcomes.

Mechanisms of behavioural maintenance: Long-term effects of theory-based interventions to promote safe water consumption

Theory-based interventions can enhance people’s safe water consumption, but the sustainability of these interventions and the mechanisms of maintenance remain unclear. We investigated these questions based on an extended theory of planned behaviour. Seven hundred and ten (445 analysed) randomly selected households participated in two cluster-randomised controlled trials in Bangladesh. Study 1 promoted switching to neighbours’ arsenic-safe wells, and Study 2 promoted switching to arsenic-safe deep wells. Both studies included two intervention phases. Structured interviews were conducted at baseline (T1), and at 1-month (T2), 2-month (T3) and 9-month (T4) follow-ups. In intervention phase 1 (between T1 and T2), commitment-based behaviour change techniques – reminders, implementation intentions and public commitment – were combined with information and compared to an information-only control group. In phase 2 (between T2 and T3), half of each phase 1 intervention group was randomly assigned to receive either commitment-based techniques once more or coping planning with reminders and information. Initial well-switching rates of up to 60% significantly declined by T4: 38.3% of T2 safe water users stopped consuming arsenic-safe water. The decline depended on the intervention. Perceived behavioural control, intentions, commitment strength and coping planning were associated with maintenance. In line with previous studies, the results indicate that commitment and reminders engender long-term behavioural change.

Pilot Test of an Adapted, Evidence-Based HIV Sexual Risk Reduction Intervention for Homeless Women.

Women experiencing homelessness are at heightened risk for HIV, yet risk reduction interventions specifically designed for this population are lacking. This study reports on a pilot efficacy trial of a brief evidence-based intervention, Sister To Sister (STS), that we specifically adapted for homeless women in the temporary/emergency settings where they typically seek services. Seventy-nine women, recruited from three service sites in Los Angeles County, were assigned to the 40-min adapted STS intervention or an information-only control group. At 30-day follow-up, intervention participants reported significantly greater condom use, intentions to use condoms, and sexual impulse control (as well as marginally higher positive condom beliefs and condom self-efficacy) compared to control participants. Results provide preliminary evidence that HIV risk reduction can be achieved for homeless women through a brief skill-based intervention. A randomized controlled trial employing a longer follow-up period to monitor outcomes will be necessary to determine efficacy of the adapted intervention.

Targeting tobacco in a community-based addiction recovery cohort: Results from a computerized, brief, randomized intervention trial

IntroductionNearly 80% of substance dependent individuals also use tobacco, and smoking cessation efforts during treatment for other substance use is associated with similar or even improved outcomes. However, smoking cessation is not routinely addressed during treatment for substance use disorders. The present study tested a computerized brief motivational intervention (C-BMI) for smoking cessation in an understudied population: a cohort recruited from a recovery community organization (RCO) center. MethodsFollowing baseline assessment, participants were randomly assigned to either a 30-minute C-BMI plus access to free nicotine replacement therapy (NRT), or an information-only control group plus NRT access. ResultsReductions in CO were observed for both groups. Quit rates in the C-BMI group (5%–7%, vs. 0% for the control group) approximated those observed elsewhere for physician advice and minimal counseling. Participants in the C-BMI group were also more likely to express a desire to quit. ConclusionsComputer-delivered smoking cessation interventions within RCOs appear feasible. These organizations treat a wide variety of individuals, and C-BMIs for smoking in this context have the potential to reduce smoking-related morbidity and mortality.

Behavioral treatment of chronic insomnia in older adults: does nocturia matter?

To evaluate the impact of nocturia on the therapeutic response of chronic insomnia to behavioral treatment in older adults. Secondary analysis of a randomized clinical trial designed to assess the efficacy of brief behavioral treatment of insomnia (BBTI) vs. an information-only control (IC) in 79 community-dwelling older adults with chronic insomnia. For the current analysis, participants were stratified into 2 groups: those with self-reported nocturia at baseline i.e., ≥ 1 void/night (N = 30; 16 IC, 14 BBTI) and those without nocturia (N = 49; 24 IC, 25 BBTI). We then determined the impact of BBTI on sleep, sleep quality, and nocturia as assessed by self-report, actigraphy, and polysomnography. Individuals without baseline nocturia responded well to BBTI with significant decrease in sleep latency, wake after sleep onset, and total sleep time assessed by sleep diary and actigraphy; these changes were significantly greater than those in the IC group. In comparison, changes in the same sleep parameters among participants with nocturia were not significantly different from the IC control. Although BBTI showed significant improvement in sleep quality in groups with and without nocturia (as assessed by PSQI and sleep diary), the effect size of these improvements was larger in those without nocturia than in those with nocturia (PSQI d = 0.82 vs. 0.53, diary sleep quality d = 0.83 vs. 0.51). These secondary analyses suggest that brief behavioral treatment of insomnia may be more efficacious in improving insomnia in participants without nocturia. Addressing nocturia may improve the efficacy of behavioral insomnia treatment.

A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods

BackgroundPhysical inactivity and a poor diet predict lifestyle diseases such as diabetes, cardiovascular disease, and certain types of cancer. Marked declines in physical activity occur during late adolescence, coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours. The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning. As actively engaging young people in initiatives based on health messages is challenging, we also tested the efficacy of financial incentives in promoting initial engagement with the programme.Methods/designA three-arm cluster-randomised design was used. Participants were school pupils from Year 11 and 13 (i.e., in their final year of study), aged 16–18 years. To reduce contamination effects, the unit of randomisation was school. Participants were randomly allocated to receive (i) a 12-week behavioural support intervention consisting of six appointments, (ii) a behavioural support intervention plus incentives (totalling £40), or (iii) an information-only control group. Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician. Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process. Consistent with self-determination theory, all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation. The primary outcome was objectively assessed physical activity (via GT1M accelerometers). Secondary outcome measures were diet, motivation and habit strength. Data were collected at baseline, post-intervention (12 weeks) and 12 months.DiscussionFindings of this trial will provide valuable insight into the feasibility of promoting autonomous engagement in healthy physical activity and dietary habits among school leavers. The research also provides much needed data and detailed information related to the use of incentives for the initial promotion of young peoples’ behaviour change during this important transition.Trial registrationThe trial is registered as Current Controlled Trials ISRCTN55839517.

Randomized controlled trial of a telephone-based intervention for child fruit and vegetable intake: long-term follow-up

Telephone-based interventions can be effective in increasing child fruit and vegetable intake in the short term (<6 mo). The long-term efficacy of such interventions, however, is unknown. The primary aim of this study was to determine whether the short-term (<6 mo) impact of a telephone-based intervention on children's fruit and vegetable intake was sustained over a longer term. A secondary aim of the study was to assess the long-term impact of the intervention on the intake of foods high in fat, salt, or sugar (noncore foods). The study used a cluster randomized controlled trial design. Parents were recruited from Australian preschools between February and August 2010 and allocated to receive an intervention consisting of print materials and 4 telephone-counseling calls delivered over 1 mo or to a print information-only control group. The primary endpoint for the trial was the 18-mo postbaseline follow-up. Linear regression models were used to assess between-group differences in child consumption of fruit and vegetables and noncore foods by subscales of the Children's Dietary Questionnaire. Fruit and vegetable subscale scores were significantly higher, indicating greater child fruit and vegetable intake, among children in the intervention group at the 12-mo (16.77 compared with 14.89; P < 0.01) but not the 18-mo (15.98 compared with 16.82; P = 0.14) follow-up. There were no significant differences between groups at either of the follow-up periods in the noncore food subscale score. Further research to identify effective maintenance strategies is required to maximize the benefits of telephone-based interventions on child diet.

Telehealth Remote Monitoring for Community-Dwelling Older Adults with Chronic Obstructive Pulmonary Disease

To determine if self-monitoring via home-based telehealth equipment could, when combined with ongoing remote monitoring by a nurse, reduce the incidence of hospitalizations and emergency department (ED) presentations for people with chronic obstructive pulmonary disease (COPD). A randomized controlled trial was used to compare the outcomes for participants receiving the telehealth equipment and monitoring with those for participants in an information-only control group, over a period of 6 months. Participants receiving the telehealth intervention were taught to measure and record their vital signs (blood pressure, weight, temperature, pulse, and oxygen saturation levels) on a daily basis. These were then transmitted automatically via telephone to a secure Web site where they were monitored each day by the telehealth nurse. The telehealth group had fewer ED presentations and hospital admissions and a reduced length of stay in comparison with the control group. These results were not statistically significant. However, the reduction in health service use was large enough to result in significant cost savings, with the annual cost savings of the telehealth group compared with the control group being $2,931 per person. Telehealth monitoring of patient vital signs reduced health service utilization for individuals with COPD and resulted in significant cost savings. In terms of individual health benefits, improvements in participants' self-management behaviors and control over their condition was evident.

What makes group MET work? A randomized controlled trial of college student drinkers in mandated alcohol diversion.

Nationally, college drinkers exhibit the highest rates of alcohol consumption and represent the largest percentage of problem drinkers. Group motivational enhancement therapy (GMET) has been found to catalyze problem drinking reductions among college student samples. Although research supporting the use of single-session GMET in college samples (general and mandated) is emergent, no studies have evaluated a comprehensive model of the potential active ingredients of this group intervention. College students (N = 206; 88% White; 63% men; M age = 18.6) mandated to a university alcohol diversion program were randomly assigned to 1 of 3 conditions: the standard-of-care 2-session "Focus on Alcohol Concerns" education group (FAC), a single GMET, or a single alcohol information-only control group (AI) to evaluate the role of 5 putative mediators: readiness to change, self-efficacy, perceived risk, norm estimates, and positive drinking expectancies. At 3- and 6-month follow-ups, GMET students demonstrated greater reductions in problem drinking outcomes (drinks per drinking day, hazardous drinking symptoms, and alcohol-related problems). Of the 5 mediators proposed, only self-efficacy emerged as a significant mediator.

Development of a Web-Based Program to Improve Communication About Sex

Adolescent sexual risk behavior is a serious and prevalent problem among American youth. Mothers may play a key role in discussing sex and sexual risk behavior with their adolescent children. However, mothers may lack the knowledge and skills to successfully communicate. The purpose of this study was to develop a Web site to teach mothers how to communicate with their children about sex and to demonstrate the efficacy of this Web-based program. This pilot study included 35 rural, low-income mothers of middle-school adolescents. Mothers were randomly assigned to either the Web-based experimental group or written information-only control group. Mothers in the experimental group received computers and Internet access to the Web-based program, peer support, and expert advice from a pediatric nurse practitioner. Major findings of the study were that the Web-based intervention was equally effective at improving mothers' knowledge, communication skills, and self-efficacy as the written material control and that low-income rural women who have had little to no prior experience with computers can effectively learn Web-based health-related information. Future implications for nursing are discussed.

An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. The psychoeducational intervention was successful in increasing compliance with vaginal dilation. This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

A community-based walking trial to improve neighborhood quality of life in older adults: a multilevel analysis

Few studies have considered the neighborhood as a context in which to examine the physical activity and quality of life relationship. The goal of this study was to evaluate the effects of a neighborhood walking program on quality of life among older adults. It was designed as a randomized trial involving a multilevel design with neighborhoods corresponding to primary sampling units and residents to secondary units. Five hundred eighty-two community-dwelling senior residents (65 years of age or older) in neighborhoods in the northeast metropolitan area of Portland, Oregon, were recruited through telephone, direct mail, and referrals. The walking intervention was delivered at the neighborhood level. Neighborhoods (N = 56) were randomly assigned to a 6-month, 3 times per week, leader-led walking group activity (n = 28) or an information-only control group (n = 28). Primary outcome measures included SF-12 (Physical, Mental summary scores) and life satisfaction (SWLS); the secondary outcome measure was neighborhood walking activity, assessed at baseline, 3 months, and 6 months of the study period. Compared to the control neighborhoods, results from multilevel, longitudinal analyses indicated significant improvements in the primary outcomes of SF-12 Physical (p < .05), SF-12 Mental (p < .05) summary scores, and SWLS (p < .05), over the course of the 6-month intervention. A significant increase was also observed in the secondary outcome of walking activity (p < .05). Implementing a neighborhood-based walking program of low to moderate intensity is feasible and beneficial for promoting quality of life among senior residents at a community level.

The gynecological implant patient

Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer.Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic–III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up.Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation.Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.