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

• ClinicalTrials.gov Identifier: NCT04295837
• Recruitment Status: Completed
• First Posted: March 5, 2020
• Last Update Posted: April 28, 2022
• Sponsor: Parker Research Institute
• Collaborators: University of Southern Denmark; VIA University College
• Information provided by (Responsible Party): Eva Ejlersen Wæhrens, Parker Research Institute

Tracking Information

• First Submitted Date: December 5, 2019
• First Posted Date: March 5, 2020
• Last Update Posted Date: April 28, 2022
• Actual Study Start Date: December 9, 2019
• Actual Primary Completion Date: July 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2021)

• 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
• 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.

Original Primary Outcome Measures (submitted: March 4, 2020)

• 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
• Change in self-reported ADL ability - with the ADL-Questionnaire (ADL-Q) [ Time Frame: Week 10 ]
  Self-report questionnaire 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.

Current Secondary Outcome Measures (submitted: January 19, 2021)

• 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
• 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
• 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
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: March 4, 2020)

• 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
• 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
• 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
• Change in self-reported satisfaction with ADL ability - with the ADL-Questionnaire (ADL-QS) [ Time Frame: Week 10 ]
  Self-report questionnaire 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.
• Change in self-reported satisfaction with ADL ability - with the ADL-Questionnaire (ADL-QS) [ Time Frame: Week 27 ]
  Self-report questionnaire 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.
• Change in self-reported ADL ability - with the ADL-Questionnaire (ADL-Q) [ Time Frame: Week 27 ]
  Self-report questionnaire 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.

Current Other Pre-specified Outcome Measures (submitted: January 19, 2021)

• Occupational Balance Questionnaire (OBQ11) [ Time Frame: Week 10 ]
  Assessing occupational balance
• Occupational Balance Questionnaire (OBQ11) [ Time Frame: Week 27 ]
  Assessing occupational balance
• EuroQoL 5 dimensions (EQ-5D) [ Time Frame: Week 10 ]
  Quality of life
• EuroQoL 5 dimensions (EQ-5D) [ Time Frame: Week 27 ]
  Quality of life
• 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.
• 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.
• General Health (SF36-SF1) [ Time Frame: Week 10 ]
  Perceived general health on 5-point ordinal scale
• General Health (SF36-SF1) [ Time Frame: Week 27 ]
  Perceived general health on 5-point ordinal scale
• 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".
• 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".

Original Other Pre-specified Outcome Measures (submitted: March 4, 2020)

• Occupational Balance Questionnaire [ Time Frame: Week 10 ]
  Assessing occupational balance
• Occupational Balance Questionnaire [ Time Frame: Week 27 ]
  Assessing occupational balance
• EuroQoL 5 dimensions (EQ-5D) [ Time Frame: Week 10 ]
  Quality of life
• EuroQoL 5 dimensions (EQ-5D) [ Time Frame: Week 27 ]
  Quality of life
• 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.
• 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.

Descriptive Information

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

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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Chronic Conditions, Multiple

Intervention

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

Study Arms

• Experimental: 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.
  Intervention: Other: ABLE
• Active Comparator: Usual care
  Community-based occupational therapy addressing ADL task performance issues among persons living with chronic conditions
  Intervention: Other: Usual Care

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2022): 78
• Original Estimated Enrollment (submitted: March 4, 2020): 80
• Actual Study Completion Date: October 21, 2021
• Actual Primary Completion Date: July 20, 2021 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT04295837
• Other Study ID Numbers: 145
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Eva Ejlersen Wæhrens, Parker Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Parker Research Institute
• Original Study Sponsor: Same as current

Collaborators

• University of Southern Denmark
• VIA University College

Investigators

• Principal Investigator: Eva E Wæhrens, PhD; The Parker Research Institute, Bispebjerg and Frederiksberg Hospital

• PRS Account: Parker Research Institute
• Verification Date: April 2022