Protocol for a Randomized Controlled Trial evaluating the ABLE program, aiming at enhancing the ADL ability among people living with chronic conditions

Background: Persons living with chronic conditions often have decreased ability to perform Activities of Daily Living (ADL) tasks, stressing a need to develop and evaluate intervention programs addressing decreased ADL ability. Guided by the British Medical Research Council’s guidance (MRC) on how to develop and evaluate complex interventions, the program “A Better everyday LifE” (ABLE), a home-based intervention program, was developed and feasibility tested. The current phase concerns a full-scale evaluation of the ABLE program, including evaluation of effectiveness, processes and cost-effectiveness.
Material and Methods: The design involves a randomized controlled trial with an internal pilot. Eighty home dwelling persons living with chronic conditions, experiencing problems performing ADL, are randomized to either intervention (ABLE) or control (usual care).
Co-primary outcomes are self-reported ADL ability measured using ADL-Questionnaire (ADL-Q) and observed ADL motor ability measured using Assessment of Motor and Process Skills (AMPS). Secondary outcomes are perceived satisfaction with ADL task performance and observed ADL process ability. Data is collected at baseline, post intervention and six months after baseline. Process evaluation data is collected using registration forms, logbooks and semi-structured qualitative interviews.
The economic evaluation will be performed from a health care sector perspective with 6 months follow-up. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL ability.
Results: A protocol paper for evaluation of the ABLE program, based on the MRC guidance.
Conclusion: The protocol represents the foundation of a transparent evaluation.