Evaluating a complex intervention addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a randomised controlled trial (ABLE) (original) (raw)
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BMJ open, 2018
The number of persons living with a chronic condition is increasing worldwide. Conditions are considered chronic when lasting 1 year or more and requiring ongoing medical attention and/or limiting activities of daily living (ADL). Besides medical treatment, physical exercise to improve body functions is recommended and prescribed. However, improvements in body functions do not necessarily improve ability to perform ADL. Thus, it is necessary to develop interventions aiming directly at enhancing ADL ability. As a part of the research programme 'A Better Everyday Life', the first version of the ABLE intervention programme was developed. This feasibility study examine the perceived value and acceptability of the ABLE programme by evaluating the fidelity, reach, dose and potential outcomes using a pretest and post-test design involving 30 persons living with chronic conditions. Qualitative interviews among occupational therapists delivering and participants receiving the ABLE pr...
Pilot and Feasibility Studies
Background The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated. Methods The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following...
Pilot and Feasibility Studies, 2021
Background The “A Better everyday LifE” (ABLE) intervention was developed to accommodate the need of a program addressing ability to perform activities of daily living (ADL) in persons with chronic conditions living at home. During intervention development, it is necessary to evaluate relevant aspects of the feasibility of a program. Thus, the aim was to evaluate the feasibility of content and delivery of ABLE version 1.0. Methods A one group pre- and post-test design was applied. Thirty persons with chronic conditions, two occupational therapists (OTs), and five occupational therapy students (OTSs) participated. ABLE 1.0 is an 8-week program consisting of ADL evaluation (session 1); goal setting and reasons for ADL problems (session 2); intervention (sessions 3–7); and re-evaluation (final session), conducted in the clients’ home-setting and local area. Sessions 1–4 and the final session was mandatory. To evaluate the feasibility of content and delivery, the OTs, after each session...
BMC Health Services Research, 2014
Background: Many cancer patients have problems performing activities of daily living (ADL). A randomised controlled trial was designed to examine the effects of an ADL intervention in addition to standard treatment and care in a hospital setting. The objective of this article was to present the study and to analyse the feasibility of the recruitment process and the intervention. Methods: Adult disabled cancer patients at Naestved Hospital in Denmark were enrolled between 1 March 2010 and 30 June 2011 and randomised into an ADL intervention or to a control group. The intervention was performed by occupational therapists. The feasibility of the recruitment was analysed with regard to success in achieving the estimated number of participants and identification of barriers, and feasibility of the intervention was based on calculations of patient attendance and patient acceptability. The primary outcome of the randomised controlled trial was patients' health-related quality of life 2 and 8 weeks after baseline. Results: A total of 118 disabled cancer patients were enrolled in the study over a time span of 16 months. Very few meetings between occupational therapist and patient were cancelled. Time spent on the intervention varied considerably, but for the majority of patients, time consumption was between 1-3 hours. Conclusions: Despite difficulties with recruitment, participation was considered feasible and the intervention was accepted among patients. Missing data in the follow-up period were mostly due to death among participants. Very few participants declined to complete questionnaires during follow-up.
Clinical Study Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial
Occupational therapy international, 2018
To determine effect size and feasibility of experimental occupational therapy (OT) intervention in addition to standard care in a population of complex patients undergoing rehabilitation in a hospital-home-based setting. Method. 40 complex patients admitted to the rehabilitation ward of the Local Health Authority-Research Institute of Reggio Emilia (Italy) were randomized in a parallel-group, open-label controlled trial. Experimental OT targeting occupational needs in the areas of self-care, productivity, and leisure was delivered by occupational therapists. Standard care consisted of taskoriented rehabilitation delivered by a multiprofessional team. Results. The experimental OT intervention was completed by 75% of patients assigned to this group. The average changes in the Canadian Occupational Performance Measure (COPM) performance score significantly and clinically favored experimental OT [−3,06 (−4.50; −1.61); delta > 2 points, resp.]. Similar trends were detected for COPM satisfaction and independence in instrumental activities of daily living (ADL). At follow-up, level of social participation was higher for patients treated with experimental OT (p = 0 043) than for controls. Conclusions. Experimental OT was feasible in complex patients in a hospital-home-based setting. It ameliorated both patients’ performance and satisfaction in carrying out relevant activities and improved independence in instrumental ADL. The trial is registered with ClinicalTrials.gov NCT02677766.
Scandinavian journal of occupational therapy, 2015
Several factors facilitate or hinder efficacy research in occupational therapy. Strategies are needed, therefore, to support the successful implementation of trials. To assess the feasibility of conducting a randomised controlled trial (RCT). The main feasibility objectives of this study were to assess the process, resources, management, and scientific basis of a trial RCT. A total of 10 occupational therapists, between the ages of 30 and 55 (M 43.4; SD 8.3) with seven to 26 years' (M 14.3; SD 6.1) experience, participated in this study. Qualitative data collected included minutes of meetings, reports, and field notes. The data were analysed based on the principles of content analysis, using feasibility objectives as the main categories. Data analysis revealed strengths in relation to retention and inclusion criteria of participants, the study protocol, study organisation, and the competence of researchers. Weaknesses were found related to recruitment, randomisation, data collec...
American Journal of Occupational Therapy, 2020
Importance: Occupational therapy can play a role in primary care management of chronic diseases among older adults. Objective: To assess the feasibility of delivering a primary care occupation-focused intervention (Integrated PRimary care and Occupational therapy for Aging and Chronic disease Treatment to preserve Independence and Functioning, or i-PROACTIF) for older adults with chronic disease. Design: Feasibility study comparing i-PROACTIF with complex care management using a two-group randomized controlled trial design with data gathered at baseline and during and after the 8-wk intervention. Setting: Family medicine clinic serving an urban, low-income, working-class community. Outcomes and Measures: Feasibility indicators were recruitment, retention, utility of clinical assessments, and acceptability of interventions assessed through feedback surveys completed by patients and primary care providers (PCPs). Patient outcomes, including perspectives on chronic illness care, occupa...
The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 2004
Background. Disability in basic activities of daily living (ADLs) implies a loss of independence and increases the risk for hospitalization, nursing home admission, and death. Little is known about ways by which ADL disability can be prevented or reversed. The authors evaluated the efficacy of the Health Enhancement Program in preventing and reducing ADL disability in community-dwelling older adults. Methods. The authors analyzed data from a 12-month, randomized, single-blinded, controlled trial of a disability prevention, chronic disease self-management program involving 201 adults aged 70 years and older that was conducted from February 1995 to June 1996 at a senior center in western Washington state. Activities of daily living disability incidence, improvement, and worsening were assessed using intention-to-treat methods. Results. The cumulative incidence of ADL disability among those who were not ADL disabled at baseline (n ¼ 56 in the intervention group, n ¼ 57 in the control group) was modestly lower in the intervention group than in the control group at 12 months (14.3% vs 21.3%, p ¼ .466). Cumulative improvement in ADL function among those who reported any ADL disability at baseline (n ¼ 41 in the intervention group, n ¼ 43 in the control group) was greater in the intervention group at 12 months (80.5% vs 46.5%, p ¼ .026). The likelihood for ADL improvement was greater in the intervention group compared with controls at 12 months (adjusted hazard ratio, 1.84; 95% confidence interval, 1.05 to 3.22; p ¼ .020). Cumulative worsening of ADL function was slightly lower in the intervention group at 12 months (18.6% vs 26.5%, p ¼ .237). Intervention participants tended to be at lower risk for ADL worsening (adjusted hazard ratio, 0.71; 95% confidence interval, 0.38 to 1.30; p ¼ .266) compared with control participants. Conclusion. The Health Enhancement Program intervention led to improved ADL functioning in those who were disabled initially and thereby offers a promising strategy for limiting or reversing functional decline in disabled elderly persons.
2006
Background. It is unclear how well self-reports and clinician ratings of performance in the instrumental activities of daily living (IADLs; household maintenance tasks) correspond and why they may differ. Methods. We assessed clinician-rated IADL performance using an occupational therapy protocol, the Assessment of Motor and Process Skills (AMPS). AMPS and self-rated IADL disability were compared in two groups of nondemented