Evidence map›Paper›PMID 31142350›Full record

ArticleTrials2019

Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185].

Natalie Nguyen, Regina Thalhammer, Katrin Beutner, Susanne Saal, Ricarda Servaty, Hanna Klingshirn, Andrea Icks, Kristina Freyberg, Markus Vomhof, Ulrich Mansmann and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact, top 92% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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

13 authors at 5 institutions in 1 country.

Natalie NguyenInstitute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle, Saale, Germany.ORCID http://orcid.org/0000-0003-0243-6994
Regina ThalhammerFaculty of Applied Health and Social Sciences, Rosenheim Technical University of Applied Sciences, Hochschulstraße 1, 83024, Rosenheim, Germany.
Katrin BeutnerInstitute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle, Saale, Germany.
Susanne SaalInstitute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle, Saale, Germany.
Ricarda ServatyFaculty of Applied Health and Social Sciences, Rosenheim Technical University of Applied Sciences, Hochschulstraße 1, 83024, Rosenheim, Germany.
Hanna KlingshirnInstitute for Medical Information Processing, Biometry and Epidemiology, Faculty of Medicine, Ludwig-Maximilians-Universität München, Munich, Germany.
Andrea IcksInstitute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Kristina FreybergDepartment of Medical Controlling, University Hospital Bonn, Bonn, Germany.
Markus VomhofInstitute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Ulrich MansmannInstitute for Medical Information Processing, Biometry and Epidemiology, Faculty of Medicine, Ludwig-Maximilians-Universität München, Munich, Germany.
Lien LeInstitute for Medical Information Processing, Biometry and Epidemiology, Faculty of Medicine, Ludwig-Maximilians-Universität München, Munich, Germany.
Martin MüllerFaculty of Applied Health and Social Sciences, Rosenheim Technical University of Applied Sciences, Hochschulstraße 1, 83024, Rosenheim, Germany. martin.mueller@th-rosenheim.de.
Gabriele MeyerInstitute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle, Saale, Germany.
Martin Luther University Halle-Wittenberg · DELudwig-Maximilians-Universität München · DERosenheim Technical University of Applied Sciences · DEDeutsches Diabetes-Zentrum e.V. · DEUniversity Hospital Bonn · DE

Funding

Bundesministerium für Bildung und Forschung 01GL1706ABundesministerium für Bildung und Forschung 01GL1706BBundesministerium für Bildung und Forschung 01GL1760C
6 · The paper itself

Abstract

backgroundNursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study. METHODS/

designThis multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65 years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level. The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level. The implementation strategy comprises a facilitators' workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents' participation and activities after 12 months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents' quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost-utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation. DISCUSSION: We expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals.

trial registrationDRKS, DRKS00015185 . Registered on 1 August 2018. Universal Trial Number U1111-1218-1555. Registered on 26 July 2018.

Indexed as

ContractureJoint DiseasesNursing HomesSocial ParticipationCluster AnalysisCost-Benefit AnalysisHumansMulticenter Studies as TopicOutcome Assessment, Health CarePatient ParticipationQuality of LifeRandomized Controlled Trials as TopicSample SizeDisability and Health (ICF); Complex intervention; Multicentre cluster randomised controlled trialJoint contractures; Participation; Activities; Nursing homes; International Classification of Functioning

Identifiers

PMID31142350
PMCPMC6542100
OpenAlexW2947833948

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.