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)

Vita Hagelskjær, Kristina Tomra Nielsen, Cecilie von Bulow, Lisa Gregersen Oestergaard, Maud Graff, Eva Ejlersen Wæhrens, Vita Hagelskjær, Kristina Tomra Nielsen, Cecilie von Bulow, Lisa Gregersen Oestergaard, Maud Graff, Eva Ejlersen Wæhrens

Abstract

Introduction: The 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 analysis: The 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 dissemination: Danish 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 number: NCT04295837.

Keywords: diabetes & endocrinology; neurology; public health; rehabilitation medicine; rheumatology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Graphical illustration of the A Better everyday LifE (ABLE) 2.0 trial.
Figure 2
Figure 2
Schedule of enrolment, interventions, and outcome assessments. ABLE, A Better everyday LifE (experimental group); ADL-I, activities of daily living-Interview; AMPS, Assessment of Motor and Process Skills; CWP-Q, Client-Weighted Problems Questionnaire; EQ5D, EuroQool 5-dimension; OBQ11, Occupational Balance Questionnaire; SF1 of SF36, First question of the MOS 36-item Short Form Survey Instrument; UOT, usual occupational therapy (control group).

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