Evidence map›Paper›PMID 26112220›Full record

Trial reportBMJ open2015

Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care.

Anneke van Dijk-de Vries, Marloes A van Bokhoven, Bjorn Winkens, Berend Terluin, J André Knottnerus, Trudy van der Weijden, Jacques Th M van Eijk

Open access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 5 pooled it
1.6field-weighted citation impact, top 15% 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

18 citing papers in PubMed, 5 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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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

7 authors at 2 institutions in 1 country.

Anneke van Dijk-de VriesDepartment of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands Department of Social Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
Marloes A van BokhovenDepartment of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
Bjorn WinkensDepartment of Methodology and Statistics, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
Berend TerluinDepartment of General Practice and Elderly Care Medicine, VU University Medical Centre, EMGO Institute for Health and Care Research, Amsterdam, The Netherlands.
J André KnottnerusDepartment of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
Trudy van der WeijdenDepartment of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
Jacques Th M van EijkDepartment of Social Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands.
Maastricht University · NLEMGO Institute for Health and Care Research · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effectiveness of biopsychosocial Self-Management Support (SMS) delivered by practice nurses in routine diabetes care.

designA pragmatic cluster-randomised controlled trial within a hybrid effectiveness-implementation study design. Practice nurses were cluster-randomised.

settingA regional care group in the Netherlands consisting of 77 family practices. The study involved practice nurses (n=40) providing care to approximately 4000 patients with diabetes.

participantsPatients with type 2 diabetes (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and diabetes-related reduced daily functioning.

interventionPractice nurses in the intervention arm (n=19) were trained to integrate SMS into their routine consultations. SMS included detection of patients with emotional distress and reduced daily functioning, and supporting them when needed through problem solving and reattribution techniques. Practice nurses in the control arm (n=21) provided usual care.

main outcome measuresThe primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning. Secondary measures included patients' diabetes-related distress, quality of life, autonomy and participation, self-efficacy, self-management and glycaemic control. Outcomes were measured at baseline and at 4-month and 12-month follow-ups.

resultsOnly 16 of the 117 patients in the intervention arm (14%) who were found eligible by the posted research-driven screening questionnaire were detected by their practice nurses. Extra consultations for the self-management support were delivered to only 11 study participants. In the control arm, 147 patients received usual care. Multilevel analyses showed no significant differences in outcomes between the intervention and control arms.

conclusionsSMS in its present form was not effective. The research-driven screening to select trial participants appeared to be inconsistent with nurse-led detection in routine practice. Adequate follow-up moments need to be built in to overcome barriers resulting from tension between the implementation and effectiveness parts of hybrid studies. TRIAL REGISTRATION NUMBER: Current Controlled Trials NTR2764.

Indexed as

Activities of Daily LivingAgedCluster AnalysisDiabetes Mellitus, Type 2FemaleHumansMaleMiddle AgedNursesPrimary Health CareSelf CareStress, PsychologicalTreatment OutcomePRIMARY CAREPUBLIC HEALTH

Identifiers

PMID26112220
PMCPMC4486946
OpenAlexW2310238495

What OpenQuestion holds

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LicenceCC BY-NC
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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.