A Better Everyday Life Among Persons With Chronic Conditions

NCT ID: NCT04295837

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2021-10-21

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.

Conditions

Chronic Conditions, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

ABLE

Intervention Type: OTHER

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

Usual care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Standard occupational therapy

Interventions

ABLE

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

Intervention Type: OTHER

Usual Care

Standard occupational therapy

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

VIA University College

OTHER

Sponsor Role: collaborator

Parker Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Eva Ejlersen Wæhrens

Senior researcher, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva E Wæhrens, PhD

Role: PRINCIPAL_INVESTIGATOR

The Parker Research Institute, Bispebjerg and Frederiksberg Hospital

Locations

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

Frederiksberg, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 34836902 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34116727 (View on PubMed)

Other Identifiers

145

Identifier Type: -

Identifier Source: org_study_id