Comprehensive Self-management Intervention Research Articles

Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study.

Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression. This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers. A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability. Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention. Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake.

A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial.

Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse. The primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention. We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation. This project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington's institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025. This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities. ClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542. PRR1-10.2196/46307.

An Integrated Clinician, Patient, and Researcher Partnership to Develop Interventions for People with Multiple Sclerosis

<h3>Research Objectives</h3> People with Multiple Sclerosis (MS) face challenges managing complex symptoms and navigating daily life. Self-management interventions may help overcome these challenges, but research is lacking on how to tailor self-management interventions for people with MS. This study describes a clinician-researcher-stakeholder partnership to design, pilot, and evaluate the feasibility of a new self-management intervention "Self-management Education and Learning Forum for People with MS (SELF for MS)." <h3>Design</h3> SELF for MS reflects an integrated, iterative clinician-stakeholder-researcher development process involving several key steps: 1) review of the clinical and self-management evidence base, 2) stakeholder needs assessment, 3) development of an Advisory Committee, and 4) iterative program development. <h3>Setting</h3> A comprehensive MS care center in urban, Southeastern USA. <h3>Participants</h3> Clinicians (speech language pathologists, neurologists, physical therapists, exercise specialists, psychologists), MS stakeholders (people with MS and care partners), and MS researchers collaborated to develop SELF for MS through an iterative research and design process. <h3>Interventions</h3> Not applicable. <h3>Main Outcome Measures</h3> The outcome of the described clinician-researcher-stakeholder partnership is the development and pilot testing of the SELF for MS program. <h3>Results</h3> SELF for MS was successfully developed over a two and a half-year period. The engagement of clinicians and MS stakeholders in partnership with MS researchers was instrumental to creating an intervention that meets patient needs in a clinical setting. <h3>Conclusions</h3> An iterative approach involving clinicians, MS stakeholders, and MS researchers resulted in a comprehensive self-management intervention centered on the needs of people with MS while reflecting best clinical practice. <h3>Author(s) Disclosures</h3> No disclosures.

Cognitive Behavioral Therapy-Based Comprehensive Self-Management Program Improves Presenteeism in Persons with Irritable Bowel Syndrome: A Secondary Data Analysis.

Individuals with irritable bowel syndrome (IBS) are more likely to miss work (absenteeism), have reduced work effectiveness (presenteeism) and experience activity impairment. This study compared the effect of a comprehensive self-management (CSM) intervention program (incorporating cognitive behavioral therapy, diet education and relaxation) versus usual care on work- and activity-impairments in adults with IBS. This secondary data analysis used daily diaries and Work Productivity and Activity Impairment in Irritable Bowel Syndrome (WPAI-IBS) questionnaire data collected at baseline, 3, 6 and 12 months post-randomization from 160 adults with IBS. Mixed-effects modeling was used to compare the effect of CSM versus usual care on work- and activity-related outcomes. The effect of CSM was shown to be superior to usual care in improving WPAI-IBS and diary-measured presenteeism, overall work productivity loss and activity impairment with sustained effects up to 12 months post-randomization (all p < 0.05). Moreover, the CSM intervention was found to be particularly beneficial for IBS patients with greater baseline work and activity impairments (all p < 0.05). The CSM intervention may bring benefits to individuals and society through improving symptoms and reducing presenteeism associated with IBS.

A Comprehensive Self-Management Program With Diet Education Does Not Alter Microbiome Characteristics in Women With Irritable Bowel Syndrome.

Changes in diet and lifestyle factors are frequently recommended for persons with irritable bowel syndrome (IBS). It is unknown whether these recommendations alter the gut microbiome and/or whether baseline microbiome predicts improvement in symptoms and quality of life following treatment. Therefore, the purpose of this study was to explore if baseline gut microbiome composition predicted response to a Comprehensive Self-Management (CSM) intervention and if the intervention resulted in a different gut microbiome composition compared to usual care. Individuals aged 18-70 years with IBS symptoms ≥6 months were recruited using convenience sampling. Individuals were excluded if medication use or comorbidities would influence symptoms or microbiome. Participants completed a baseline assessment and were randomized into the eight-session CSM intervention which included dietary education and cognitive behavioral therapy versus usual care. Questionnaires included demographics, quality of life, and symptom diaries. Fecal samples were collected at baseline and 3-month post-randomization for 16S rRNA-based microbiome analysis. Within the CSM intervention group (n = 30), Shannon diversity, richness, and beta diversity measures at baseline did not predict benefit from the CSM intervention at 3 months, as measured by change in abdominal pain and quality of life. Based on both alpha and beta diversity, the change from baseline to follow-up microbiome bacterial taxa did not differ between CSM (n = 25) and usual care (n = 25). Baseline microbiome does not predict symptom improvement with CSM intervention. We do not find evidence that the CSM intervention influences gut microbiome diversity or composition over the course of 3 months.

Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS

ObjectiveAdults with irritable bowel syndrome (IBS) often report extraintestinal pain, fatigue, and sleep disturbances in addition to abdominal pain. Few interventions have sought to reduce these extraintestinal symptoms within the IBS population. To address this, we compared the effects of a comprehensive self-management (CSM) intervention to a control intervention (usual care) on extraintestinal pain, fatigue, and sleep disturbances among patients with IBS. MethodData were obtained from 243 IBS patients participating in two CSM intervention trials. Daily symptom diaries were collected at baseline, 3 and 6 months post-randomization. Daily symptoms of headache, backache, muscle pain, joint pain, fatigue, sleepiness during the day, sleep quality, and refreshed by sleep were analyzed. Analysis of covariance was used to determine the effects of the intervention on each symptom at 3 and 6 months controlling for ‘study’ and baseline symptom levels. ResultsPatients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months. The CSM group also reported significantly decreased joint pain at 3 months compared to usual care, but not 6 months. No significant difference was found for muscle pain. ConclusionsAn existing CSM intervention is effective in reducing fatigue and sleep disturbances. However, mixed results for extraintestinal pain indicates a need to better differentiate between underlying mechanisms. Addressing such symptoms is important to decrease the overall burden of IBS, reduce health care expenditures, and improve patients' quality of life.Trial Registration: NCT00907790; NCT00167635

2294 Do patient comorbidities impact the effectiveness of a COPD self-management program?

OBJECTIVES/SPECIFIC AIMS: Chronic obstructive pulmonary disease (COPD) is a leading cause of both hospitalizations and readmissions in the United States, and about 1 in 5 hospitalized patients with COPD will be readmitted within 30 days. COPD-focused self-management programs are frequently used to help patients better manage their symptoms and prevent hospitalization. However, while the majority of patients with COPD have at least one comorbidity, most trials of COPD self-management programs either excluded patients with significant comorbidities or did not analyze the impact of comorbidities on patient outcomes. Using data from the BREATHE trial of a COPD self-management program, this study aims to determine if patient post-intervention outcomes differ based on the intensity and type of patient comorbidities. METHODS/STUDY POPULATION: In total, 240 patients hospitalized for COPD were randomly assigned to either a comprehensive self-management intervention or usual transitional care. Primary outcomes for this trial were the number of COPD-related hospitalizations and emergency department visits at 6 months and changes in COPD-specific quality of life. To determine whether patient comorbidities modify the effect of the self-management intervention on readmission and quality of life outcomes, we will compare patient outcomes across groups stratified by comorbidity burden (Charlson Comorbidity Index) and type (baseline diagnosis of congestive heart failure, diabetes, and depression). In addition, we will use regression analysis with interaction terms to test for interaction between comorbidity burden/type and intervention assignment. RESULTS/ANTICIPATED RESULTS: We hypothesize that the effect of the self-management intervention will differ in patients with greater comorbidity burden due to competing medical demands for patients with multimorbidity. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this study will help clinicians better target disease-specific self-management programs to the groups of patients with COPD who are likely to receive the greatest benefit from this type of intervention.

BetaMe: impact of a comprehensive digital health programme on HbA1c and weight at 12 months for people with diabetes and pre-diabetes: study protocol for a randomised controlled trial

BackgroundLong-term conditions (LTCs) are the biggest contributor to health loss in New Zealand. The economic cost and burden on the health system is substantial and growing. Self-management strategies offer a potential way to reduce the pressure on health services. This study evaluates a comprehensive self-management programme (the BetaMe programme) delivered by mobile and web-based technologies for people with Type 2 diabetes (T2DM) and pre-diabetes. The primary aim of this study is to evaluate the effectiveness of the BetaMe programme versus usual care among primary care populations in improving the control of T2DM and pre-diabetes, as measured by change in HbA1c and weight over 12 months.MethodsParticipants will be recruited through two primary healthcare organisations and a Māori healthcare provider in New Zealand (n = 430). Eligible participants will be 18 to 75 years old, with T2DM or pre-diabetes, with an HbA1c of 41–70 mmol/mol up to 2 years prior to study commencement. Eligible participants who consent to participate will be individually randomised to the control arm (usual care) or intervention arm (usual care and BetaMe). The programme consists of a 16-week core followed by a maintenance period of 36 weeks. It incorporates (1) individualised health coaching, (2) goal setting and tracking, (3) peer support in an online forum and (4) educational resources and behaviour-change tools. The primary outcome measures are change in HbA1c and weight at 12 months. Secondary outcomes are changes in waist circumference, blood pressure, patient activation and diabetes-specific behaviours. All outcomes will be assessed at 4 and 12 months for the total study population and for Māori and Pacific participants specifically. All primary analyses will be based on intention-to-treat. Primary analysis will use linear mixed models comparing mean outcome levels adjusted for initial baseline characteristics at 12 months.DiscussionThis is a randomised controlled trial of a comprehensive self-management intervention for people with diabetes and pre-diabetes. If effective, this programme would allow healthcare providers to deliver an intervention that is person-centred and supports the self-care of people with T2DM, pre-diabetes and potentially other LTCs.Trial registrationAustralian New Zealand Clinical Trials Registry, ID: ACTRN12617000549325. Registered on 19 April 2017.

COMT Val158Met Polymorphism and Symptom Improvement Following a Cognitively Focused Intervention for Irritable Bowel Syndrome.

Our nurse-delivered comprehensive self-management (CSM) program, a cognitive behavioral therapy intervention, is effective in reducing gastrointestinal and psychological distress symptoms in patients with irritable bowel syndrome (IBS). Findings from non-IBS studies indicate that the catechol-O-methyltransferase (COMT) Val158Met polymorphism may moderate the efficacy of cognitive behavioral therapy. It is unknown whether this COMT polymorphism is associated with symptom improvements in patients with IBS. We tested whether this COMT Val158Met polymorphism influences the efficacy of our 2-month CSM intervention. We analyzed data from two published randomized controlled trials of CSM. The combined European American sample included 149 women and 23 men with IBS (CSM, n = 111; usual care [UC], n = 61). The primary outcomes were daily reports of abdominal pain, depression, anxiety, and feeling stressed measured 3 and 6 months after randomization. Secondary outcomes were additional daily symptoms, retrospective psychological distress, IBS quality of life, and cognitive beliefs about IBS. The interaction between COMT Val158Met polymorphism and treatment group (CSM vs. UC) in a generalized estimating equation model tested the main objective. At 3 months, participants with at least one Val allele benefited more from CSM than did those with the Met/Met genotype (p = .01 for anxiety and feeling stressed, and p < .16 for abdominal pain and depression). The moderating effect of genotype was weaker at 6 months. Persons with at least one Val allele may benefit more from CSM than those homozygous for the Met allele. Future studies with larger and more racially diverse samples are needed to confirm these findings. Parent studies were registered at ClinicalTrials.gov (NCT00167635 and NCT00907790).

Balance of Autonomic Nervous System Predicts Who Benefits from a Self-management Intervention Program for Irritable Bowel Syndrome.

Background/AimsTo determine if potential biomarkers can be used to identify subgroups of people with irritable bowel syndrome (IBS) who will benefit the most or the least from a comprehensive self-management (CSM) intervention.MethodsIn a two-armed randomized controlled trial a CSM (n = 46) was compared to a usual care (n = 46) group with follow-up at 3 and 6 months post randomization. Biomarkers obtained at baseline included heart rate variability, salivary cortisol, interleukin-10 produced by unstimulated peripheral blood mononuclear cells, and lactulose/mannitol ratio. Linear mixed models were used to test whether these biomarkers predicted improvements in the primary outcomes including daily abdominal pain, Gastrointestinal Symptom score and IBS-specific quality of life.ResultsThe nurse-delivered 8-session CSM intervention is more effective than usual care in reducing abdominal pain, reducing Gastrointestinal Symptom score, and enhancing quality of life. Participants with lower nighttime high frequency heart rate variability (vagal modulation) and increased low frequency/high frequency ratio (sympathovagal balance) had less benefit from CSM on abdominal pain. Salivary cortisol, IL-10, and lactulose/mannitol ratio were not statistically significant in predicting CSM benefit. Baseline symptom severity interacts with treatment, namely the benefit of CSM is greater in those with higher baseline symptoms.ConclusionsCognitively-focused therapies may be less effective in reducing abdominal pain in IBS patients with higher sympathetic tone. Whether this a centrally-mediated patient characteristic or related to heightened arousal remains to be determined.

What Strategies Do Patients With Irritable Bowel Syndrome Continue to Use Following a 9-Week Comprehensive Self-Management Program?

Introduction: The aims of this study were to identify strategies patients with irritable bowel syndrome (IBS) continued to use following a 9-week comprehensive self-management (CSM) program. Methods: This secondary analysis includes data collected at the last CSM session and 6 and 12 months post-randomization from adult with IBS randomized to receive CSM intervention. During the last CSM session, subjects identified CSM strategies they intended to continue using in each of the following categories: diet, relaxation, and alternative thinking. For each identified strategy, subjects were asked at the 6- and 12-month follow-up times to rate how often they used it on a 5-point scale (1 = not at all to 5 = almost always). Individual strategies were categorized into 9 themes: 1) meal timing/frequency, 2) trigger food reduction/elimination, 3) eating behaviors (e.g., avoid eating out, eat more slowly, etc.), 4) balanced diet (e.g., fiber, fluids, etc.), 5) specific relaxation strategies (e.g., abdominal breathing, body scan, etc.), 6) lifestyle behaviors (e.g., exercise, hobbies, etc.), 7) thought distortions (e.g., all or nothing thinking, overgeneralization of negative, etc.), 8) challenging beliefs (e.g., perfectionism, self-esteem, etc.) and 9) problem-solving skills (e.g., find support, refocus, etc.).Table 1Results: The majority of subjects were female (N=88, 87%) and the mean age was 44 years (SD=14). The first column of the table shows, for each theme, the percentage of subjects who reported at their last CSM session their intention to continue using strategies from that theme. The second column shows the percentage of subjects who reported at 12 months post-randomization that they have continued to use strategies from that theme at least 2 days a week. Conclusion: Our 9-week CSM program resulted in sustainable behavioral changes for IBS symptom management in the majority of our subjects. An advantage of the multi-component CSM intervention is that patients can determine which strategies are most effective at alleviating their IBS symptoms and continue to use them.

USING SELF‐MANAGEMENT INTERVENTIONS TO ADDRESS GENERAL EDUCATION BEHAVIORAL NEEDS: ASSESSMENT OF EFFECTIVENESS AND FEASIBILITY

A comprehensive self‐management intervention was utilized to increase the on‐task behavior of three African American students within an urban middle‐school setting. The intervention was designed to necessitate minimal management on the part of the general education classroom teacher by utilizing an electronic prompting device, as well as a centralized intervention coordinator for the management of training, implementation, and progress monitoring. Results suggested that implementation of the intervention resulted in improvement in on‐task behavior across all three students; however, problems with inconsistent implementation necessitated that modifications be made to the intervention procedures. Implications for the design and implementation of self‐management interventions within general education secondary‐level settings are discussed.

Comprehensive Self-Management Reduces the Negative Impact of Irritable Bowel Syndrome Symptoms on Sexual Functioning

Women with irritable bowel syndrome (IBS) report sexual dysfunction. Comprehensive self-management (CSM) intervention has been shown to reduce gastrointestinal, psychological, and somatic symptoms in IBS women. Whether this intervention also reduces sexual dysfunction is not known. We sought to compare demographic and clinical factors in IBS women with and without sexual dysfunction as defined by the Arizona sexual experiences scale (ASEX) and to test the effects of CSM treatment on sexual dysfunction scores and on the sexual relations subscale of an IBS quality of life (IBSQOL) scale which measures the effect of IBS on sexual QOL. IBS (Rome II) women enrolled in a randomized clinical trial of CSM treatment were characterized as having sexual dysfunction (N = 89) or not (N = 86) at baseline based on ASEX criteria. Baseline characteristics and symptoms were compared between the two groups. Post-intervention changes were compared between the CSM and the usual care arms of the randomized trial. Women meeting ASEX criteria for sexual dysfunction were older, had higher lifetime depression and antidepressant use, more primary care/MD visits, fewer mental healthcare visits, and greater sleep disturbance than those without sexual dysfunction. No significant group differences in gastrointestinal or somatic symptoms were observed. Compared with usual care treatment, CSM increased sexual QOL scores and had a weaker effect on ASEX scores. Severity of IBS symptoms at baseline did not differ between IBS women with or without sexual dysfunction. The CSM intervention can reduce the effect of IBS on sexual QOL.