Evidence map›Paper›PMID 34911711›Full record

Trial reportBMJ open2021

Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial.

Yolanda Ramallo-Fariña, Amado Rivero-Santana, Lidia García-Pérez, Miguel Angel García-Bello, Ana Maria Wägner, Himar Gonzalez-Pacheco, Leticia Rodríguez-Rodríguez, Sybille Kaiser-Girardot, Guillermo Monzón-Monzón, Carolina Guerra-Marrero and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report 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 NCT01657227 (Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT01657227 nacompletednot on this map

Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus

TypeinterventionalSponsorServicio Canario de SaludRan2013 to 2016Enrolled2,334ConditionsType 2 Diabetes MellitusArmsIntervention to patients, Intervention to professionals, Usual care
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Factors associated with patient empowerment in Spanish adults with type 2 diabetes: A cross-sectional analysis.Health expectations : an international journal of public participation in health care and health policy · 2022
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  9. Review
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

15 authors at 4 institutions in 1 country.

Yolanda Ramallo-FariñaCanary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain yramfar@sescs.es.ORCID 0000-0002-1541-3989
Amado Rivero-SantanaCanary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.
Lidia García-PérezCanary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.ORCID 0000-0002-5626-8116
Miguel Angel García-BelloCanary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.
Ana Maria WägnerDepartment of Endocrinology and Nutrition, Insular University Hospital of Gran Canaria, Las Palmas de Gran Canaria, Spain.
Himar Gonzalez-PachecoCanary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.
Leticia Rodríguez-RodríguezCanary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.
Sybille Kaiser-GirardotEvaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.ORCID 0000-0002-8195-1021
Guillermo Monzón-MonzónEvaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.
Carolina Guerra-MarreroEvaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.
Carmen Daranas-AguilarEvaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.
Margarita Roldán-RuanoEvaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.
Montserrat CarmonaResearch Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain.
Pedro G Serrano-AguilarResearch Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain.
INDICA Team
Health Research Institute of the Balearic Islands · ESServicio Canario de la Salud · ESInstituto de Salud Carlos III · ESUniversidad de Las Palmas de Gran Canaria · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term.

participantsA total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres.

settingPrimary Care Centers in Canary Islands (Spain).

interventionThe intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI). OUTCOME MEASURE: Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables.

resultsCompared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).

conclusionsAssessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227.

Indexed as

Diabetes Mellitus, Type 2Behavior TherapyHealth PersonnelHumansPatient Reported Outcome MeasuresQuality of Lifediabetes & endocrinologyhealth informaticsprimary carequality in health care

Identifiers

PMID34911711
PMCPMC8679133
OpenAlexW4200065335

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.