ArticleBMC family practice2006
The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411].
Article in BMC family practice, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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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.
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.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.
- Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2017Pooled it
- The impact of individualised cardiovascular disease (CVD) risk estimates and lifestyle advice on physical activity in individuals at high risk of CVD: a pilot 2 x 2 factorial understanding risk trial.Cardiovascular diabetology · 2008Trial
- Patient Engagement and Coaching for Health: The PEACH study--a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol.BMC family practice · 2007Trial
- A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual.BMC family practice · 2006Trial
- Using Normalisation Process Theory (NPT) to develop an intervention to improve referral and uptake rates for self-management education for patients with type 2 diabetes in UK primary care.BMC health services research · 2022Article
- Article
- Assessing self-efficacy in type 2 diabetes management: validation of the Italian version of the Diabetes Management Self-Efficacy Scale (IT-DMSES).Health and quality of life outcomes · 2018Article
- Diabetes self-management arrangements in Europe: a realist review to facilitate a project implemented in six countries.BMC health services research · 2014Review
- Assessment of the benefits of user involvement in health research from the Warwick Diabetes Care Research User Group: a qualitative case study.Health expectations : an international journal of public participation in health care and health policy · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. METHODS/
designIn a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. DISCUSSION: This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.
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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.