A Better Everyday Life Among Persons With Chronic Conditions

NCT04295837 | Completed

• 1 other identifier: 145
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Conditions, Multiple

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)

  Week 10

• Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)

  Week 27

• Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)

  Week 27

• Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)

  Week 10

• Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)

  Week 27

Other Outcomes (10)

• Occupational Balance Questionnaire (OBQ11)

  Week 10

• Occupational Balance Questionnaire (OBQ11)

  Week 27

• EuroQoL 5 dimensions (EQ-5D)

  Week 10

Study Arms (2)

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.

Other: ABLE

Usual care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

ABLE OTHER

Home-based occupational therapy compensatory programme addressing activities of daily living

ABLE - A Better everday LifE

Usual Care OTHER

Standard occupational therapy

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Parker Research Institute: lead
• University of Southern Denmark: collaborator
• VIA University College: collaborator

Study Sites (1)

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

Frederiksberg, 2000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 34836902 DERIVED

• 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.

  PMID: 34116727 DERIVED

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva E Wæhrens, PhD

  The Parker Research Institute, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, associate professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: March 5, 2020
• Study Start: December 9, 2019
• Primary Completion: July 20, 2021
• Study Completion: October 21, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)