Chronic Conditions, Multiple
Conditions
Brief summary
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
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.
Interventions
OTHERABLE
Home-based occupational therapy compensatory programme addressing activities of daily living
OTHERUsual Care
Standard occupational therapy
Sponsors
University of Southern Denmark
VIA University College
Parker Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS) | Week 10 | Observation-based measure of ADL ability - motor |
| Change in self-reported ADL ability - with the ADL-Interview (ADL-I) | Week 10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS) | Week 10 | Observation-based measure of ADL ability - process |
| Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS) | Week 27 | Observation-based measure of ADL ability - motor |
| Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS) | Week 10 | 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. |
| Change in self-reported ADL ability - with the ADL-Interview (ADL-I) | Week 27 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| EuroQoL 5 dimensions (EQ-5D) | Week 10 | Quality of life |
| Transition Questionnaire (TRANS-Q) | Week 10 | Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied. |
| General Health (SF36-SF1) | Week 10 | Perceived general health on 5-point ordinal scale |
| Client-Weighted-Problems (CWP) | Week 10 | Self-reported weight of identified problems, need for help and hope for the future on an 11-point ordinal scale ranging from '0' representing not at all to '10' representing to a high extent. |
| Occupational Balance Questionnaire (OBQ11) | Week 10 | Assessing occupational balance |
Countries
Denmark
Outcome results
None listed