Evidence map›Paper›PMID 34836902›Full record

ArticleBMJ open2021

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).

Vita Hagelskjær, Kristina Tomra Nielsen, Cecilie von Bulow, Lisa Gregersen Oestergaard, Maud Graff, Eva Ejlersen Wæhrens

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04295837 (A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 78% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04295837 nacompletednot on this map

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

TypeinterventionalSponsorParker Research InstituteRan2019 to 2021Enrolled78ConditionsChronic Conditions, MultipleArmsABLE, Usual Care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 0 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Vita HagelskjærCopenhagen University, Bispebjerg and Frederiksberg Hospital, The Parker Institute, Copenhagen, Denmark vita.hagelskjaer@regionh.dk.ORCID 0000-0002-0342-8024
Kristina Tomra NielsenCopenhagen University, Bispebjerg and Frederiksberg Hospital, The Parker Institute, Copenhagen, Denmark.ORCID 0000-0002-4944-9453
Cecilie von BulowCopenhagen University, Bispebjerg and Frederiksberg Hospital, The Parker Institute, Copenhagen, Denmark.
Lisa Gregersen OestergaardDepartment of Public Health, University of Southern Denmark, Odense, Syddanmark, Denmark.ORCID 0000-0003-2255-1391
Maud GraffDepartment of Rehabilitation & Scientific Institute for Quality of Care Research, Radboud University Medical Center, Nijmegen, Netherlands.
Eva Ejlersen WæhrensCopenhagen University, Bispebjerg and Frederiksberg Hospital, The Parker Institute, Copenhagen, Denmark.
University of Southern Denmark · DKRadboud University Nijmegen · NLUniversity College Capital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

Indexed as

Activities of Daily LivingQuality of LifeCost-Benefit AnalysisHumansQuality-Adjusted Life YearsRandomized Controlled Trials as TopicSelf ReportSurveys and Questionnairesdiabetes & endocrinologyneurologypublic healthrehabilitation medicinerheumatology

Identifiers

PMID34836902
PMCPMC8628341
OpenAlexW3197778288

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.