Chronic Conditions, MultipleABLENCT04295837
A Better Everyday Life Among Persons With Chronic Conditions
A study testing ABLE in people with Chronic Conditions, Multiple, run by Parker Research Institute at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Conditions, Multiple
- What is being tested?
- ABLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Dec 2019to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
Frederiksberg, 2000
About this study
Official title: A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons 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, 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).
Read more
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.
Read the 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.
- Conditions
- Chronic Conditions, Multiple
- Being tested
- ABLE, Usual Care
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLEOther
Home-based occupational therapy compensatory programme addressing activities of daily living
Usual CareOther
Standard occupational therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ABLE |
| Usual care | Active comparator | Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
Observation-based measure of ADL ability - motor
Measured: 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.
Measured: Week 10
Secondary outcomes (6)
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - process
Measured: Week 10
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - process
Measured: Week 27
Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - motor
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start9 Dec 2019
- Primary completion20 Jul 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Conditions, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, VIA University College
- Responsible party
- Principal investigator, Eva Ejlersen Wæhrens, Parker Research Institute
- Investigators
- Eva E Wæhrens, PhD, Principal investigator, The Parker Research Institute, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295837
- Sponsor's protocol ID
- 145
- Acronym
- ABLE
- Status last verified
- Apr 2022
- First submitted
- 5 Dec 2019
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34836902Hagelskjaer 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.
PubMed 34116727
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions
- ClinicalTrials.gov ID
- NCT04295837
- Acronym / sponsor ID
- ABLE / 145
- Conditions
- Chronic Conditions, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Parker Research InstituteUniversity, hospital or other
- Collaborators
- University of Southern Denmark, VIA University College
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABLE - A Better everday LifE | Experimental | Other: ABLEA 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 | Other: Usual CareCommunity-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABLEHome-based occupational therapy compensatory programme addressing activities of daily living | Other | ABLE - A Better everday LifE |
| Usual CareStandard occupational therapy | Other | Usual care |
Primary outcome
Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
Time frame: Week 10
Observation-based measure of ADL ability - motor
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
Time frame: 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.
6 secondary outcomes
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Time frame: Week 10
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Time frame: Week 27
Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)
Time frame: Week 27
Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
Time frame: Week 10
Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
Time frame: Week 27
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
Time frame: Week 27
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 34836902Hagelskjaer 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.
- Derived from this study: PubMed 34116727Hagelskjaer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva E Wæhrens, PhD principal investigator
The Parker Research Institute, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABLE in people with Chronic Conditions, Multiple, run by Parker Research Institute at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS) (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295837, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.