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

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).

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.

Study Overview

• Status: Completed
• Conditions: Chronic Conditions, Multiple
• Intervention / Treatment: Other: ABLE; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occupational Balance Questionnaire (OBQ11)	Assessing occupational balance	Week 10
Occupational Balance Questionnaire (OBQ11)	Assessing occupational balance	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

Collaborators and Investigators

• Sponsor: Parker Research Institute
• Collaborators: VIA University College; University of Southern Denmark
• Investigators: Principal Investigator: Eva E Wæhrens, PhD, The Parker Research Institute, Bispebjerg and Frederiksberg Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Disease; Multiple Chronic Conditions
• Other Study ID Numbers: 145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No