A Better Everyday Life Among Persons With Chronic Conditions

Chronic Conditions, Multiple Clinical Trial

— ABLE  

Official title:

A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295837
• Other study ID #: 145
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: October 21, 2021

Study information

• Verified date: April 2022
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 21, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Disease
• Multiple Chronic Conditions

Intervention

Other:
• ABLE
Home-based occupational therapy compensatory programme addressing activities of daily living
• Usual Care
Standard occupational therapy

Locations

Country	Name	City	State
Denmark	The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
Parker Research Institute	University of Southern Denmark, VIA University College

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occupational Balance Questionnaire (OBQ11)	Assessing occupational balance	Week 10
Other	Occupational Balance Questionnaire (OBQ11)	Assessing occupational balance	Week 27
Other	EuroQoL 5 dimensions (EQ-5D)	Quality of life	Week 10
Other	EuroQoL 5 dimensions (EQ-5D)	Quality of life	Week 27
Other	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
Other	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
Other	General Health (SF36-SF1)	Perceived general health on 5-point ordinal scale	Week 10
Other	General Health (SF36-SF1)	Perceived general health on 5-point ordinal scale	Week 27
Other	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
Other	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
Primary	Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)	Observation-based measure of ADL ability - motor	Week 10
Primary	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	Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)	Observation-based measure of ADL ability - process	Week 10
Secondary	Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)	Observation-based measure of ADL ability - process	Week 27
Secondary	Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)	Observation-based measure of ADL ability - motor	Week 27
Secondary	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
Secondary	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
Secondary	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