Evidence map›Paper›PMID 26631181›Full record

Trial reportTrials2015

Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial.

Anna K Davies, Nadine McGale, Steve E Humphries, Shashivadan P Hirani, Katherine E Beaney, Dauda A S Bappa, John G McCabe, Stanton P Newman

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01891786 (A Randomised Control Trial), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01891786 nacompletednot on this map

A Randomised Control Trial (RCT) to Investigate the Effectiveness of a Selfmanagement Intervention and Personalised Genetic Risk Information to Reduce Risk of Coronary Heart Disease in Patients With Type 2 Diabetes.

TypeinterventionalSponsorCity, University of LondonRan2013 to 2016Enrolled211ConditionsCoronary Heart Disease, Type 2 DiabetesArmsSelf-Management Intervention, Risk Result
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Observational
  6. Precision Health Care Elements, Definitions, and Strategies for Patients with Diabetes: A Literature Review.International journal of environmental research and public health · 2021
    Review
  7. 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

8 authors.

Anna K DaviesCentre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. Anna.Davies.2@city.ac.uk.
Nadine McGaleCentre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. nadine.mcgale.1@city.ac.uk.
Steve E HumphriesCentre for Cardiovascular Genetics, British Heart Foundation Laboratories, Institute of Cardiovascular Science, University College London, Gower Street, London, WC1E 6BT, UK. steve.humphries@ucl.ac.uk.
Shashivadan P HiraniCentre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. shashi.hirani.1@city.ac.uk.
Katherine E BeaneyCentre for Cardiovascular Genetics, British Heart Foundation Laboratories, Institute of Cardiovascular Science, University College London, Gower Street, London, WC1E 6BT, UK. katherine.beaney.12@ucl.ac.uk.
Dauda A S BappaCentre for Cardiovascular Genetics, British Heart Foundation Laboratories, Institute of Cardiovascular Science, University College London, Gower Street, London, WC1E 6BT, UK. d.bappa@ucl.ac.uk.
John G McCabeWallace House GP Surgery, 5-11 St Andrew Street, Hertford, Hertfordshire, SG14 1HZ, UK. gerry.mccabe@nhs.net.
Stanton P NewmanCentre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. Stanton.newman.1@city.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients with type 2 diabetes fail to achieve good glycaemic control. Poor control is associated with complications including coronary heart disease (CHD). Effective self-management and engagement in health behaviours can reduce risks of complications. However, patients often struggle to adopt and maintain these behaviours. Self-management interventions have been found to be effective in improving glycaemic control. Recent developments in the field of genetics mean that patients can be given personalised information about genetic- and lifestyle-associated risk of developing CHD. Such information may increase patients' motivation to engage in self-management. The Coronary Risk in Diabetes (CoRDia) trial will compare the effectiveness of a self-management intervention, with and without provision of personalised genetic- and lifestyle-associated risk information, with usual care, on clinical and behavioural outcomes, the cognitive predictors of behaviour, and psychological wellbeing. METHODS/

designParticipants will be adults aged 25-74 years registered with general practices in the East of England, diagnosed with type 2 diabetes, with no history of heart disease, and with a glycated haemoglobin level of ≥6.45% (47 mmol/mol). Consenting participants will be randomised to one of three arms: usual care control, group self-management only, group self-management plus personalised genetic- and lifestyle-associated risk information. The self-management groups will receive four weekly 2-hour group sessions, focusing on knowledge and information sharing, problem solving, goal setting and action planning to promote medication adherence, healthy eating, and physical activity. Primary outcomes are glycaemic control and CHD risk. Clinical data will be collected from GP records, including HbA1c, weight, body mass index, blood pressure, and HDL and total cholesterol. Self-reported health behaviours, including medication adherence, healthy eating and physical activity, and cognitive outcomes will be assessed by questionnaire. Measures will be taken at baseline, 3 months (questionnaire only), 6 months and 12 months post-baseline. DISCUSSION: This study will determine whether the addition of personalised genetic- and lifestyle-associated CHD risk information to a group self-management intervention improves diabetes control and CHD risk compared with group self-management and usual care. Effectiveness of the combined intervention on health behaviours cognitions theorised to predict them, and psychological outcomes will also be investigated.

trial registrationThis study has been registered at ClinicalTrials.gov; registration identifier NCT01891786 , registered 28 June 2013.

Indexed as

CounselingPrecision MedicineRisk Reduction BehaviorSelf CareAdultAgedClinical ProtocolsCognitionCoronary DiseaseDiabetes Mellitus, Type 2DietEnglandExerciseFemaleGenetic MarkersGenetic Predisposition to DiseaseGenetic Markers

Identifiers

PMID26631181
PMCPMC4668706

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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.