Clinical trial NCT04295837: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Conditions, Multiple
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: VIA University College
First posted: 2020-03-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
timeFrame: Week 10
measure: Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
timeFrame: Week 10
Secondary outcomes:
measure: Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
timeFrame: Week 10
measure: Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)
timeFrame: Week 27
measure: Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)
timeFrame: Week 27
measure: Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
timeFrame: Week 10
measure: Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)
timeFrame: Week 27
measure: Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
timeFrame: Week 27
Other outcomes:
measure: Occupational Balance Questionnaire (OBQ11)
timeFrame: Week 10
measure: Occupational Balance Questionnaire (OBQ11)
timeFrame: Week 27
measure: EuroQoL 5 dimensions (EQ-5D)
timeFrame: Week 10
measure: EuroQoL 5 dimensions (EQ-5D)
timeFrame: Week 27
measure: Transition Questionnaire (TRANS-Q)
timeFrame: Week 10
measure: Transition Questionnaire (TRANS-Q)
timeFrame: Week 27
measure: General Health (SF36-SF1)
timeFrame: Week 10
measure: General Health (SF36-SF1)
timeFrame: Week 27
measure: Client-Weighted-Problems (CWP)
timeFrame: Week 10
measure: Client-Weighted-Problems (CWP)
timeFrame: Week 27
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg
Study officials:
affiliation: The Parker Research Institute, Bispebjerg and Frederiksberg Hospital
name: Eva E Wæhrens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.