Evidence mapPaperPMID 31439049Full record

ArticleTrials2019

Efficacy of DiaLife, an education program for relatives of adult patients with diabetes - study protocol of a cluster randomized controlled trial.

M Bernard, N Müller, L Hecht, G Fabisch, A Harder, C Luck-Sikorski

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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
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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 5 institutions in 1 country.

M BernardIntegrated Research and Treatment Center Adiposity Diseases (IFB), University of Leipzig, Philipp-Rosenthal-Straße 27, 04103, Leipzig, Germany. marie.bernard@medizin.uni-leipzig.de.ORCID http://orcid.org/0000-0003-4208-4057
N MüllerDepartment of Internal Medicine III, University Hospital Jena, Am Klinikum 1, 07747, Jena, Germany.
L HechtVDBD e.V.-German Association of Diabetes Nurses and Education Experts, Habersaathstr. 31, 10115, Berlin, Germany.
G FabischVDBD e.V.-German Association of Diabetes Nurses and Education Experts, Habersaathstr. 31, 10115, Berlin, Germany.
A HarderVDBD e.V.-German Association of Diabetes Nurses and Education Experts, Habersaathstr. 31, 10115, Berlin, Germany.
C Luck-SikorskiIntegrated Research and Treatment Center Adiposity Diseases (IFB), University of Leipzig, Philipp-Rosenthal-Straße 27, 04103, Leipzig, Germany.
Association of German Engineers · DECarl von Ossietzky Universität Oldenburg · DEIFB Adiposity Diseases · DEJena University Hospital · DESRH Hochschule für Gesundheit Gera · DE

Funding

Bundesministerium für Gesundheit ZMV I 1-2517DIA004Universität Leipzig IN-1260910
6 · The paper itself

Abstract

backgroundThe global prevalence of diabetes mellitus (DM) has been increasing over recent decades. In Germany, the prevalence for DM type 1 and type 2 in adults is estimated at about 7.7%. Hence, diabetes has to be classified as a serious public health concern. Being diagnosed with DM and facing possible sequelae might have a negative impact on patients' mental and physical well-being. However, diabetes not only affects patients themselves, but also their close relatives. To improve the quality of life for patients and relatives alike, the German Association of Diabetes Nurses and Education experts (VDBD) elaborated the first education program tailor-made for relatives of diabetes patients. This article describes the concept and design of the trial evaluating the efficacy of this education program called "DiaLife-Living Together with Diabetes".

methodsThis evaluation study is a cluster randomized controlled trial, in which the study centers will be randomly assigned either to the intervention group or the control group. Study centers will recruit relatives of and patients with DM type 1 and type 2. Members of the intervention group will participate in the education program DiaLife, whereas participants randomized in the control group will act as waiting-list controls. The study will assess the efficacy of DiaLife by comparing diabetes-related knowledge between the intervention and control groups as the primary outcome for participants. As the primary outcome in patients, the Hba1c value will be assessed. In addition, diabetes-related distress, family interaction, and other secondary endpoints will be considered as secondary outcomes. Long-term efficacy will be assessed 6 and 12 months after intervention. Hierarchical regression models will be used to analyze effects over time. DISCUSSION: While there is scientific evidence for the efficacy of education programs addressed to (diabetes) patients, there is a research gap with regard to intervention studies evaluating the efficacy of education programs designed for patients' relatives. The study results will provide information on the efficacy of the DiaLife education program. In addition, factors that might hinder a successful implementation of an education program for relatives will be identified.

trial registrationGerman Clinical Trials Register, DRKS00015157 . Registered on 24 August 2018.

Indexed as

Health Knowledge, Attitudes, PracticeAdaptation, PsychologicalBiomarkersCost of IllnessDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2FamilyFamily RelationsGermanyGlycated HemoglobinHealth EducationHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTime FactorsBiomarkersGlycated Hemoglobinhemoglobin A1c protein, humanCluster randomized controlled trialDiabetesEducation programEvaluation studyRelativesTreatment

Identifiers

PMID31439049
PMCPMC6704511
OpenAlexW2969964657

What Socratic holds

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LicenceCC BY
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Registered trials

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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 Socratic graph.