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Completed

NCT Number: NCT04295837

A Better Everyday Life Among Persons 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ABLE

Other

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

Usual Care

Other

Standard occupational therapy

Primary outcomes

  1. Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)

    Time frame: Week 10

    Observation-based measure of ADL ability - motor

  2. Change in self-reported ADL ability - with the ADL-Interview (ADL-I)

    Time frame: Week 10

    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.

Secondary outcomes

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

    Time frame: Week 10

    Observation-based measure of ADL ability - process

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

    Time frame: Week 27

    Observation-based measure of ADL ability - process

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

    Time frame: Week 27

    Observation-based measure of ADL ability - motor

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

    Time frame: Week 10

    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.

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

    Time frame: Week 27

    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.

  6. Change in self-reported ADL ability - with the ADL-Interview (ADL-I)

    Time frame: Week 27

    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.

Other outcomes

  1. Occupational Balance Questionnaire (OBQ11)

    Time frame: Week 10

    Assessing occupational balance

  2. Occupational Balance Questionnaire (OBQ11)

    Time frame: Week 27

    Assessing occupational balance

  3. EuroQoL 5 dimensions (EQ-5D)

    Time frame: Week 10

    Quality of life

  4. EuroQoL 5 dimensions (EQ-5D)

    Time frame: Week 27

    Quality of life

  5. Transition Questionnaire (TRANS-Q)

    Time frame: Week 10

    Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied.

  6. Transition Questionnaire (TRANS-Q)

    Time frame: Week 27

    Perceived change in performance and satisfaction with ADL ability on a Likert scale from much less able/satisfied to fully able/satisfied.

  7. General Health (SF36-SF1)

    Time frame: Week 10

    Perceived general health on 5-point ordinal scale

  8. General Health (SF36-SF1)

    Time frame: Week 27

    Perceived general health on 5-point ordinal scale

  9. Client-Weighted-Problems (CWP)

    Time frame: Week 10

    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".

  10. Client-Weighted-Problems (CWP)

    Time frame: Week 27

    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".

Sponsors and collaborators

Lead sponsor

Parker Research Institute

Other

Collaborators

  • University of Southern Denmark
  • VIA University College

Registry information

Official study title

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

Acronym: ABLE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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