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, initiated with an internal pilot. The study will include eighty (n=80) home dwelling persons living with chronic conditions, experiencing problems performing ADL. Participants 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 measured using ADL-Q; observed ADL process ability measured using AMPS; and Goal Attainment measured using Goal-Attainment-Scaling (GAS). Data is collected at baseline, post intervention and six months after baseline. Process evaluation data are collected using registration forms 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.
Due to the Covid-19 pandemic, the study was truncated on March 11th 2020. Data collected at this time was assessed to be sufficient to answer most pilot study questions, and it was decided to turn the internal pilot into an external pilot. Based on the results of the external pilot, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual care were applied, before initiation of the full scale trial. Hence ADL-I replaced ADL-Q as primary outcome measurement. Data collection for full scale trial was initiated August 1st 2020.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
78
Home-based occupational therapy compensatory programme addressing activities of daily living
Standard occupational therapy
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
Frederiksberg, Denmark
Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
Observation-based measure of ADL ability - motor
Time frame: Week 10
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
Self-report based on interview addressing perceived ability to perform ADL tasks. Linear measures of ADL ability will be generated using Rasch measurement models. Higher scores mean more ADL ability.
Time frame: Week 10
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - process
Time frame: Week 10
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - process
Time frame: Week 27
Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - motor
Time frame: Week 27
Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
Self-report based on interview addressing satisfaction with perceived ability to perform ADL tasks. Linear measures of satisfactions with ADL ability will be generated using Rasch measurement models. Higher scores mean more satisfaction.
Time frame: Week 10
Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
Self-report based on interview addressing satisfaction with perceived ability to perform ADL tasks. Linear measures of satisfactions with ADL ability will be generated using Rasch measurement models. Higher scores mean more satisfaction.
Time frame: Week 27
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
Self-report based on interview addressing perceived ability to perform ADL tasks. Linear measures of ADL ability will be generated using Rasch measurement models. Higher scores mean more ADL ability.
Time frame: Week 27
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.