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

Parker Research Institute

Status: Completed

Conditions: Chronic Conditions, Multiple

Treatments: Other: ABLE; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04295837

145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

ABLE - A Better everday LifE

Experimental group

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.

Treatment:

Other: ABLE

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care