A Better Everyday Life Among Persons With Chronic Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions

Conditions
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Chronic Conditions, Multiple

Intervention / Treatment
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* Other: ABLE
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ one year since medical diagnosed with one or more chronic conditions Perceive problems performing ADL tasks ≥ 18 years of age Lives in own home Motivated and ready for making changes in ADL performance Motivated and ready to participate in program Communicates independently and relevant Able to understand and relevantly answer a questionnaire Exclusion Criteria: PADL problems with acute need for help (if the client does not already receive help from home carer Known substance abuse Mental illness, and/or other acute illness effecting ADL task performance Communication barriers (e.g. severe cognitive deficits; and barriers that prevents receiving information on study)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABLE - A Better everday LifE<br>A home-based occupational therapy intervention addressing ADL task performance issues among persons living with chronic conditions. The ABLE intervention is occupation-focused and -based, and follows a structured process of assessment, goalsetting, intervention and evaluation. | Other: ABLE<br>* Home-based occupational therapy compensatory programme addressing activities of daily living<br>|
| Active Comparator: Usual care<br>Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions | Other: Usual Care<br>* Standard occupational therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS) | Observation-based measure of ADL ability - motor | 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. | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS) | Observation-based measure of ADL ability - process | Week 10 | 
| Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS) | Observation-based measure of ADL ability - process | Week 27 | 
| Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS) | Observation-based measure of ADL ability - motor | 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. | 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. | 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. | Week 27 |