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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| VIA University College | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABLE - A Better everday LifE | Experimental | 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. |
|
| Usual care | Active Comparator | Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABLE | Other | Home-based occupational therapy compensatory programme addressing activities of daily living |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Occupational Balance Questionnaire (OBQ11) | Assessing occupational balance | Week 10 |
| Occupational Balance Questionnaire (OBQ11) | Assessing occupational balance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva E Wæhrens, PhD | The Parker Research Institute, Bispebjerg and Frederiksberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg | Frederiksberg | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34836902 | Derived | Hagelskjaer V, Nielsen KT, von Bulow C, Oestergaard LG, Graff M, Waehrens EE. 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). BMJ Open. 2021 Nov 26;11(11):e051722. doi: 10.1136/bmjopen-2021-051722. | |
| 34116727 |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual Care | Other | Standard occupational therapy |
|
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 |
| Week 27 |
| EuroQoL 5 dimensions (EQ-5D) | Quality of life | Week 10 |
| EuroQoL 5 dimensions (EQ-5D) | Quality of life | Week 27 |
| Transition Questionnaire (TRANS-Q) | Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied. | Week 10 |
| Transition Questionnaire (TRANS-Q) | Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied. | Week 27 |
| General Health (SF36-SF1) | Perceived general health on 5-point ordinal scale | Week 10 |
| General Health (SF36-SF1) | Perceived general health on 5-point ordinal scale | Week 27 |
| Client-Weighted-Problems (CWP) | 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". | Week 10 |
| Client-Weighted-Problems (CWP) | 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". | Week 27 |
| Hagelskjaer V, Nielsen KT, von Bulow C, Graff M, Waehrens EE. Occupational therapy addressing the ability to perform activities of daily living among persons living with chronic conditions: a randomised controlled pilot study of ABLE 2.0. Pilot Feasibility Stud. 2021 Jun 11;7(1):122. doi: 10.1186/s40814-021-00861-9. |