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 progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful). Results Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3–100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects. Conclusions Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed. Trial registration The study was registered at ClinicalTrials.gov (Identifier: NCT04295837) on December 5th, 2019. Retrospectively registered.

IntroductionThe need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council’s guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme.Methods and analysisThe evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers.Ethics and disseminationDanish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences.Trial registration numberNCT04295837