search
Back to results

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

Primary Purpose

Chronic Conditions, Multiple

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ABLE
Usual Care
Sponsored by
Parker Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Conditions, Multiple

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABLE - A Better everday LifE

Usual care

Arm Description

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.

Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions

Outcomes

Primary Outcome Measures

Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
Observation-based measure of ADL ability - motor
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.

Secondary Outcome Measures

Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - process
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - process
Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)
Observation-based measure of ADL ability - motor
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.
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.
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.

Full Information

First Posted
December 5, 2019
Last Updated
April 27, 2022
Sponsor
Parker Research Institute
Collaborators
University of Southern Denmark, VIA University College
search

1. Study Identification

Unique Protocol Identification Number
NCT04295837
Brief Title
A Better Everyday Life Among Persons With Chronic Conditions
Acronym
ABLE
Official Title
A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parker Research Institute
Collaborators
University of Southern Denmark, VIA University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Conditions, Multiple

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABLE - A Better everday LifE
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions
Intervention Type
Other
Intervention Name(s)
ABLE
Intervention Description
Home-based occupational therapy compensatory programme addressing activities of daily living
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Standard occupational therapy
Primary Outcome Measure Information:
Title
Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
Description
Observation-based measure of ADL ability - motor
Time Frame
Week 10
Title
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
Description
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.
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Description
Observation-based measure of ADL ability - process
Time Frame
Week 10
Title
Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
Description
Observation-based measure of ADL ability - process
Time Frame
Week 27
Title
Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)
Description
Observation-based measure of ADL ability - motor
Time Frame
Week 27
Title
Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
Description
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.
Time Frame
Week 10
Title
Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
Description
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.
Time Frame
Week 27
Title
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
Description
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.
Time Frame
Week 27
Other Pre-specified Outcome Measures:
Title
Occupational Balance Questionnaire (OBQ11)
Description
Assessing occupational balance
Time Frame
Week 10
Title
Occupational Balance Questionnaire (OBQ11)
Description
Assessing occupational balance
Time Frame
Week 27
Title
EuroQoL 5 dimensions (EQ-5D)
Description
Quality of life
Time Frame
Week 10
Title
EuroQoL 5 dimensions (EQ-5D)
Description
Quality of life
Time Frame
Week 27
Title
Transition Questionnaire (TRANS-Q)
Description
Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied.
Time Frame
Week 10
Title
Transition Questionnaire (TRANS-Q)
Description
Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied.
Time Frame
Week 27
Title
General Health (SF36-SF1)
Description
Perceived general health on 5-point ordinal scale
Time Frame
Week 10
Title
General Health (SF36-SF1)
Description
Perceived general health on 5-point ordinal scale
Time Frame
Week 27
Title
Client-Weighted-Problems (CWP)
Description
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".
Time Frame
Week 10
Title
Client-Weighted-Problems (CWP)
Description
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".
Time Frame
Week 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva E Wæhrens, PhD
Organizational Affiliation
The Parker Research Institute, Bispebjerg and Frederiksberg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34836902
Citation
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.
Results Reference
derived
PubMed Identifier
34116727
Citation
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.
Results Reference
derived

Learn more about this trial

A Better Everyday Life Among Persons With Chronic Conditions

We'll reach out to this number within 24 hrs