Stakeholders' Perspectives, Needs, and Barriers to Self-Management for People With Physical Disabilities Experiencing Chronic Conditions: Focus Group Study.

BACKGROUND: While self-management programs have had significant improvements for individuals with chronic conditions, less is known about the impact of self-management programs for individuals with physical disabilities who experience chronic conditions, as no holistic self-management programs exist for this population. Similarly, there is limited knowledge of how other stakeholders, such as caregivers, health experts, and researchers, view self-management programs in the context of disability, chronic health conditions, and assistive technologies. OBJECTIVE: This study aimed to obtain insight into how stakeholders perceive self-management relating to physical disability, chronic conditions, and assistive technologies. METHODS: Nine focus groups were conducted by 2 trained facilitators using semistructured interview guides. Each guide contained questions relating to stakeholders' experiences, challenges with self-management programs, and perceptions of assistive technologies. Focus groups were audio recorded and transcribed. Thematic analysis was conducted on the focus group data. RESULTS: A total of 47 individuals participated in the focus groups. By using a constructivist grounded approach and inductive data collection, three main themes emerged from the focus groups: (1) perspectives, (2) needs, and (3) barriers of stakeholders. Stakeholders emphasized the importance of physical activity, mental health, symptom management, medication management, participant centeredness, and chronic disease and disability education. Participants viewed technology as a beneficial aide to their daily self-management and expressed their desire to have peer-to-peer support in web-based self-management programs. Additional views of technology included the ability to access individualized, educational content and connect with other individuals who experience similar health conditions or struggle with caregiving duties. CONCLUSIONS: The findings suggest that the development of any web-based self-management program should include mental health education and resources in addition to physical activity content and symptom management and be cost-effective. Beyond the inclusion of educational resources, stakeholders desired customization or patient centeredness in the program to meet the overall needs of individuals with physical disabilities and caregivers. The development of web-based self-management programs should be holistic in meeting the needs of all stakeholders. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/study/NCT05481593.

Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial.

BACKGROUND/AIMS: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. METHODS: Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. RESULTS: The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. CONCLUSION: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.

A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial.

Primary care offers a familiar and accessible clinical venue for patients with obesity to receive evidence-based lifestyle interventions for weight management. However, there are numerous barriers to the implementation of such programs in primary care, and previous primary care weight loss interventions demonstrate modest and temporary effects. Weight loss treatment delivered within primary care by peer coaches may offer a viable and effective alternative. The purpose of this trial is to test the effects of weight loss treatment that includes ongoing support from a peer coach (i.e., trained, salaried community health workers) as compared to self-directed treatment. Peer coach treatment will be delivered over 18 months and includes a combination of in-person, group-based office visits and individual telephone contacts. This weight loss trial will include 375 adults with obesity (BMI = 30-50 kg/m2) randomized from 10 primary care practices. The primary outcome will be changes in body weight at month 18. Secondary outcomes will include key patient-centered outcomes, including quality-of-life, physical and social functioning, mood, and treatment satisfaction. The cost-effectiveness of the peer coach intervention will also be evaluated. If this novel intervention is effective, it could offer a practical and sustainable approach for the delivery of weight loss treatment in primary care that has the potential to improve clinical outcomes for patients, increase treatment options for primary care providers, and reduce obesity-related healthcare utilization and costs.

Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease.

OBJECTIVE: To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions. DESIGN: Cluster randomised controlled trial. SETTING: 36 general practices in the north west of England. PARTICIPANTS: 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥ 10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) long term conditions other than diabetes or heart disease; 240 (62%) were men; 360 (90%) completed the trial. INTERVENTIONS: Collaborative care included patient preference for behavioural activation, cognitive restructuring, graded exposure, and/or lifestyle advice, management of drug treatment, and prevention of relapse. Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse. Usual care was standard clinical practice provided by general practitioners and practice nurses. MAIN OUTCOME MEASURES: The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale (SCL-D13) at four months after baseline assessment. Secondary outcomes included anxiety symptoms (generalised anxiety disorder 7), self management (health education impact questionnaire), disability (Sheehan disability scale), and global quality of life (WHOQOL-BREF). RESULTS: 19 general practices were randomised to collaborative care and 20 to usual care; three practices withdrew from the trial before patients were recruited. 191 patients were recruited from practices allocated to collaborative care, and 196 from practices allocated to usual care. After adjustment for baseline depression score, mean depressive scores were 0.23 SCL-D13 points lower (95% confidence interval -0.41 to -0.05) in the collaborative care arm, equal to an adjusted standardised effect size of 0.30. Patients in the intervention arm also reported being better self managers, rated their care as more patient centred, and were more satisfied with their care. There were no significant differences between groups in quality of life, disease specific quality of life, self efficacy, disability, and social support. CONCLUSIONS: Collaborative care that incorporates brief low intensity psychological therapy delivered in partnership with practice nurses in primary care can reduce depression and improve self management of chronic disease in people with mental and physical multimorbidity. The size of the treatment effects were modest and were less than the prespecified effect but were achieved in a trial run in routine settings with a deprived population with high levels of mental and physical multimorbidity. TRIAL REGISTRATION: ISRCTN80309252.

Association of complementary and alternative medicine use, demographic factors, and perimenopausal symptoms in a multiethnic sample of women: the ENDOW study.

Complementary and alternative medicine (CAM) use is common in the United States, particularly among middle-aged women for symptoms commonly reported during perimenopause. The study examined the relationship between women's report of perimenopausal symptoms and the use of CAM and socioeconomic or cultural factors. The prevalence of CAM use was 33%; approximately 94% reported use of CAM therapies and 23% used CAM practitioners. Those who used CAM were younger and better educated; more often they reported pelvic pain and painful intercourse. The only demographic factor to predict use of alternative medicine was education.