Dataset Information

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).

ABSTRACT:

Introduction

The need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council's guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme.

Methods and analysis

The evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers.

Ethics and dissemination

Danish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences.

Trial registration number

NCT04295837.

SUBMITTER: Hagelskjær V

PROVIDER: S-EPMC8628341 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated.MethodsThe study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful).ResultsDue to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3-100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects.ConclusionsProceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed.Trial registrationThe study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

Project description:BackgroundThe "A Better everyday LifE" (ABLE) intervention was developed to accommodate the need of a program addressing ability to perform activities of daily living (ADL) in persons with chronic conditions living at home. During intervention development, it is necessary to evaluate relevant aspects of the feasibility of a program. Thus, the aim was to evaluate the feasibility of content and delivery of ABLE version 1.0.MethodsA one group pre- and post-test design was applied. Thirty persons with chronic conditions, two occupational therapists (OTs), and five occupational therapy students (OTSs) participated. ABLE 1.0 is an 8-week program consisting of ADL evaluation (session 1); goal setting and reasons for ADL problems (session 2); intervention (sessions 3-7); and re-evaluation (final session), conducted in the clients' home-setting and local area. Sessions 1-4 and the final session was mandatory. To evaluate the feasibility of content and delivery, the OTs, after each session, reported on applied intervention component(s), time-use, needed equipment, adjustments, meaningfulness, confidence, progress toward goal attainment, and side effects using registration forms. The clients reported on progress toward goal attainment, meaningfulness, and satisfaction. Clinically relevant improvements in ADL ability were identified using the ADL-Interview (ADL-I) and the Assessment of Motor and Process Skills (AMPS). Goal attainment was evaluated using the Goal Attainment Scaling (GAS).ResultsTwenty clients (67%) completed ABLE 1.0 and received four sessions (median = 4, range 4-7) each lasting between 30 and 94 min. Most frequently applied component was "Changing habits related to task performance". Generally, OTs reported having the needed equipment. Deviations from the manual were made by omission of GAS and AMPS and less than mandatory number of sessions per client. The OTs reported confidence in delivering the program and the clients perceived the program as meaningful and satisfying, and experienced progress toward goal attainment. Goal attainment was found in 52% of the goals. Sixteen (80%) clients obtained clinically relevant improvements in self-reported or observed ADL ability.ConclusionsThe content and delivery of ABLE 1.0 was feasible. However, the study revealed a need to adjust the recruitment procedure and make minor changes in the intervention manual. A pilot randomized controlled trial (RCT) study is recommended.Trial registrationThe study was registered at ClinicalTrials.gov with registration no. NCT03335709 on November 8, 2017.

Project description:BackgroundThe aging of the population and the progressive increase of life expectancy in developed countries is leading to a high incidence of age-related cerebrovascular diseases, which affect people's motor and cognitive capabilities and might result in the loss of arm and hand functions. Such conditions have a detrimental impact on people's quality of life. Assistive robots have been developed to help people with motor or cognitive disabilities to perform activities of daily living (ADLs) independently. Most of the robotic systems for assisting on ADLs proposed in the state of the art are mainly external manipulators and exoskeletal devices. The main objective of this study is to compare the performance of an hybrid EEG/EOG interface to perform ADLs when the user is controlling an exoskeleton rather than using an external manipulator.MethodsTen impaired participants (5 males and 5 females, mean age 52 ± 16 years) were instructed to use both systems to perform a drinking task and a pouring task comprising multiple subtasks. For each device, two modes of operation were studied: synchronous mode (the user received a visual cue indicating the sub-tasks to be performed at each time) and asynchronous mode (the user started and finished each of the sub-tasks independently). Fluent control was assumed when the time for successful initializations ranged below 3 s and a reliable control in case it remained below 5 s. NASA-TLX questionnaire was used to evaluate the task workload. For the trials involving the use of the exoskeleton, a custom Likert-Scale questionnaire was used to evaluate the user's experience in terms of perceived comfort, safety, and reliability.ResultsAll participants were able to control both systems fluently and reliably. However, results suggest better performances of the exoskeleton over the external manipulator (75% successful initializations remain below 3 s in case of the exoskeleton and bellow 5s in case of the external manipulator).ConclusionsAlthough the results of our study in terms of fluency and reliability of EEG control suggest better performances of the exoskeleton over the external manipulator, such results cannot be considered conclusive, due to the heterogeneity of the population under test and the relatively limited number of participants.