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Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

ABSTRACT: OBJECTIVES:This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. METHODS:Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. RESULTS:Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. DISCUSSION:Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best to implement them. If effective, the intervention represents an opportunity to transition patients from institutionally-based rehabilitative management to community-based care. The results of the process evaluation will contribute to the science of translating evidence-based programs into regular practice.

SUBMITTER: Desveaux L

PROVIDER: S-EPMC4880740 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

Desveaux Laura L Beauchamp Marla K MK Lee Annemarie A Ivers Noah N Goldstein Roger R Brooks Dina D

JMIR research protocols 20160511 2

<h4>Objectives</h4>This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments.<h4>Methods</h4>Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise pro ...[more]

PMID: 27169436

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Project description:BACKGROUND:Standardised evidenced-based materials and mechanisms to facilitate the delivery of the education component of pulmonary rehabilitation are not widely available. The aims of this study were: 1) to adapt the self-management programme Living Well with COPD (LWWCOPD) programme, for embedding in pulmonary rehabilitation; and, 2) to conduct a process evaluation of the adapted programme. METHODS:The adaptations to the LWWCOPD programme were informed by focus groups, current practice, relevant research and guideline documents. Pulmonary rehabilitation sites used the adapted programme, the LWWCOPD programme for pulmonary rehabilitation, to deliver the education component of pulmonary rehabilitation. A process evaluation was conducted: elements included reach (patients' attendance rates), dose delivered (amount of programme delivered), dose received (health professional and patient satisfaction) and fidelity (impact on patients' knowledge, understanding and self-efficacy on the Understanding COPD questionnaire). Descriptive statistics (mean, SD) were used to summarise demographics and key data from the feedback questionnaires. Qualitative feedback on the programme was collated and categorised. Changes in the Understanding COPD questionnaire were examined using paired t-tests. RESULTS:The LWWCOPD programme for pulmonary rehabilitation was delivered in eleven hospital- and community-based programmes (n=25 health professionals, n=57 patients with COPD). It consisted of six weekly 30-45 minute sessions. The process evaluation showed positive results: 62.3% of patients attended ? 4 education sessions (reach); mean (SD) 90 (10)% of the session content were delivered (dose delivered); the majority of sessions were rated as excellent or good by health professionals and patients. Patients' satisfaction was high: mean (SD) Section B of the Understanding COPD questionnaire: 91.67 (9.55)% (dose received). Knowledge, understanding and self-efficacy improved significantly: mean change (95% CI): Section A of the Understanding COPD questionnaire: 26.75 (21.74 to 31.76)%, BCKQ 10.64 (6.92 to 14.37)% (fidelity). CONCLUSION:This rigorous process evaluation has demonstrated that the LWWCOPD programme for pulmonary rehabilitation can be used to deliver high quality, consistent and equitable education sessions during hospital and community-based pulmonary rehabilitation. This programme is now available worldwide (http://www.livingwellwithcopd.com/living-well-and-pulmonary-rehabilitation.html). TRIAL REGISTRATION:This study was registered with clinicaltrials.gov (reference number: NCT01226836).

Project description:BackgroundGlobal attention to the study of nutrition program implementation has been inadequate yet is critical for effective delivery and impact at scale.ObjectivesThe objective of this mixed-methods process evaluation study was to measure the recruitment, fidelity, and reach of a large-scale, community-based nutrition program in Malawi.MethodsThe nutrition program delivered a small-quantity lipid-based nutrient supplement (SQ-LNS) and social and behavior change communication (SBCC) to improve infant and young child feeding (IYCF) and water, sanitation, and hygiene (WASH) practices in households with children aged 6-23 mo. Program monitoring and evaluation data were used to measure program recruitment, reach, and fidelity. Structured direct observations and knowledge questionnaires with program volunteers measured quality aspects of program fidelity. The number of times activities were done correctly was used to tabulate proportions used to represent program functioning.ResultsHalf (49.5%) of eligible children redeemed program benefits by 8 mo of age during the first 4 y of program implementation. Implementation of training activities for SBCC cadres exceeded program targets (100.6%), but the completion of certain modules (breastfeeding and complementary feeding) was lower (22.9% and 18.6%, respectively). Knowledge of IYCF, WASH, and SQ-LNS messages by volunteers was >85% for most messages, except ability to list the 6 food groups (35.7%). Structured direct observations of SQ-LNS distributions indicated high fidelity to program design, whereas those of household-level counseling sessions revealed lack of age-appropriate messaging. Program reach showed participation in monthly distribution sessions of 81.0%, group counseling of 93.3%, and individual-level counseling of 36.9%.ConclusionsThis community-based nutrition program was implemented with high fidelity and quality, with specific interventions requiring further attention. The documentation of implementation contributes to our understanding about how program impacts were achieved.

Project description:BackgroundGoal setting is considered 'best practice' in stroke rehabilitation; however, there is no consensus regarding the key components of goal setting interventions or how they should be optimally delivered in practice. We developed a theory-based goal setting and action planning framework (G-AP) to guide goal setting practice. G-AP has 4 stages: goal negotiation, goal setting, action planning & coping planning and appraisal & feedback. All stages are recorded in a patient-held record. In this study we examined the implementation, acceptability and perceived benefits of G-AP in one community rehabilitation team with people recovering from stroke.MethodsG-AP was implemented for 6 months with 23 stroke patients. In-depth interviews with 8 patients and 8 health professionals were analysed thematically to investigate views of its implementation, acceptability and perceived benefits. Case notes of interviewed patients were analysed descriptively to assess the fidelity of G-AP implementation.ResultsG-AP was mostly implemented according to protocol with deviations noted at the planning and appraisal and feedback stages. Each stage was felt to make a useful contribution to the overall process; however, in practice, goal negotiation and goal setting merged into one stage and the appraisal and feedback stage included an explicit decision making component. Only two issues were raised regarding G-APs acceptability: (i) health professionals were concerned about the impact of goal non-attainment on patient's well-being (patients did not share their concerns), and (ii) some patients and health professionals found the patient-held record unhelpful. G-AP was felt to have a positive impact on patient goal attainment and professional goal setting practice. Collaborative partnerships between health professionals and patients were apparent throughout the process.ConclusionsG-AP has been perceived as both beneficial and broadly acceptable in one community rehabilitation team; however, implementation of novel aspects of the framework was inconsistent. The regulatory function of goal non-attainment and the importance of creating flexible partnerships with patients have been highlighted. Further development of the G-AP framework, training package and patient held record is required to address the specific issues highlighted by this process evaluation. Further evaluation of G-AP is required across diverse community rehabilitation settings.

Project description:BackgroundPatients with chronic obstructive pulmonary disease (COPD) experience deficits in exercise capacity and physical activity as their disease progresses. Pulmonary rehabilitation (PR) can enhance exercise capacity of patients and it is crucial for patients to maintain a lifestyle which is long-term physically active. This study aimed to develop a home-based rehabilitation mHealth system incorporating behavior change techniques (BCTs) for COPD patients, and evaluate its technology acceptance and feasibility.MethodsGuided by the medical research council (MRC) framework the process of this study was divided into four steps. In the first step, the prescription was constructed. The second step was to formulate specific intervention functions based on the behavior change wheel theory. Subsequently, in the third step we conducted iterative system development. And in the last step two pilot studies were performed, the first was for the improvement of system functions and the second was to explore potential clinical benefits and validate the acceptance and usability of the system.ResultsA total of 17 participants were enrolled, among them 12 COPD participants completed the 12-week study. For the clinical outcomes, Six-Minute Walk Test (6MWT) showed significant difference (P = .023) over time with an improvement exceeded the minimal clinically important difference (MCID). Change in respiratory symptom (CAT score) was statistically different (P = .031) with a greater decrease of - 3. The mMRC levels reduced overall and showed significant difference. The overall compliance of this study reached 82.20% (± 1.68%). The results of questionnaire and interviews indicated good technology acceptance and functional usability. The participants were satisfied with the mHealth-based intervention.ConclusionsThis study developed a home-based PR mHealth system for COPD patients. We showed that the home-based PR mHealth system incorporating BCTs is a feasible and acceptable intervention for COPD patients, and COPD patients can benefit from the intervention delivered by the system. The proposed system played an important auxiliary role in offering exercise prescription according to the characteristics of patients. It provided means and tools for further individuation of exercise prescription in the future.

Project description:To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation.Mixed methods process evaluation in a randomised feasibility study.Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge.Sixty-one older adults (aged ?65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers.Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions.Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context.Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goal-setting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions.Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care.ISRCTN22464643; Post- results.

Dataset Information

Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

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Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

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