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A Better Everyday Life Among Persons With Chronic Conditions (ABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04295837
Recruitment Status : Completed
First Posted : March 5, 2020
Last Update Posted : April 28, 2022
Sponsor:
Collaborators:
University of Southern Denmark
VIA University College
Information provided by (Responsible Party):
Eva Ejlersen Wæhrens, Parker Research Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Conditions, Multiple Other: ABLE Other: Usual Care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions
Actual Study Start Date : December 9, 2019
Actual Primary Completion Date : July 20, 2021
Actual Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABLE - A Better everday LifE
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
Home-based occupational therapy compensatory programme addressing activities of daily living
Active Comparator: Usual care
Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions
 Other: Usual Care
Standard occupational therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS) [ Time Frame: Week 10 ]
    Observation-based measure of ADL ability - process

  2. Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS) [ Time Frame: Week 27 ]
    Observation-based measure of ADL ability - process

  3. Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS) [ Time Frame: Week 27 ]
    Observation-based measure of ADL ability - motor

  4. Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS) [ Time Frame: 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.

  5. Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS) [ Time Frame: Week 27 ]
    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.

  6. Change in self-reported ADL ability - with the ADL-Interview (ADL-I) [ Time Frame: 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 Outcome Measures:
  1. Occupational Balance Questionnaire (OBQ11) [ Time Frame: Week 10 ]
    Assessing occupational balance

  2. Occupational Balance Questionnaire (OBQ11) [ Time Frame: Week 27 ]
    Assessing occupational balance

  3. EuroQoL 5 dimensions (EQ-5D) [ Time Frame: Week 10 ]
    Quality of life

  4. EuroQoL 5 dimensions (EQ-5D) [ Time Frame: Week 27 ]
    Quality of life

  5. Transition Questionnaire (TRANS-Q) [ Time Frame: Week 10 ]
    Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied.

  6. Transition Questionnaire (TRANS-Q) [ Time Frame: Week 27 ]
    Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied.

  7. General Health (SF36-SF1) [ Time Frame: Week 10 ]
    Perceived general health on 5-point ordinal scale

  8. General Health (SF36-SF1) [ Time Frame: Week 27 ]
    Perceived general health on 5-point ordinal scale

  9. Client-Weighted-Problems (CWP) [ Time Frame: 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".

  10. Client-Weighted-Problems (CWP) [ Time Frame: Week 27 ]
    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".


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295837


Locations
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Denmark
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Parker Research Institute
University of Southern Denmark
VIA University College
Investigators
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Principal Investigator: Eva E Wæhrens, PhD The Parker Research Institute, Bispebjerg and Frederiksberg Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eva Ejlersen Wæhrens, Senior researcher, associate professor, Parker Research Institute
ClinicalTrials.gov Identifier: NCT04295837    
Other Study ID Numbers: 145
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Chronic Disease
Multiple Chronic Conditions
Pathologic Processes
Disease Attributes