Update on the collaborative interventions for circulation and depression (COINCIDE) trial: changes to planned methodology of a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease

Trials

Linda Gask¹  Sarah Knowles¹  Chris Roberts¹  Farheen Jeeva¹  Linda Davies¹  Mark Hann¹  Waquas Waheed⁵  Chris Keyworth¹  Isabel Adeyemi¹  Kate Roughley¹  Clare Baguley³  Chris J Gibbons¹  Charlotte Garrett¹  Andrea Cherrington¹  Carolyn Chew-Graham¹  Peter Bower¹  Chris Dickens⁴  Karina Lovell²  Peter A Coventry¹ 

[1] Greater Manchester Collaboration for Leadership in Applied Health Research and Care, Institute of Population Health and Manchester Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK;School of Nursing, Midwifery & Social Work and Manchester Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK;IAPT North West Programme Field Lead, NHS North West, Manchester M60 7LP, UK;Peninsula College of Medicine and Dentistry, University of Exeter and Peninsula Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC), Exeter, Devon EX1 2LU, UK;Lancashire Care NHS Foundation Trust, Preston PR5 6AW, UK

关键词: Collaborative care;    Primary care;    Coronary heart disease;    Diabetes;    Depression;   

Others  :  1094048
DOI  :  10.1186/1745-6215-14-136

 received in 2013-01-19, accepted in 2013-04-18,  发布年份 2013

【 摘 要 】

Background

The COINCIDE trial aims to evaluate the effectiveness and cost-effectiveness of a collaborative care intervention for depression in people with diabetes and/or coronary heart disease attending English general practices.

Design

This update details changes to the cluster and patient recruitment strategy for the COINCIDE study. The original protocol was published in Trials (http://www.trialsjournal.com/content/pdf/1745-6215-13-139.pdf webcite). Modifications were made to the recruitment targets in response to lower-than-expected patient recruitment at the first ten general practices recruited into the study. In order to boost patient numbers and retain statistical power, the number of general practices recruited was increased from 30 to 36. Follow-up period was shortened from 6 months to 4 months to ensure that patients recruited to the trial could be followed up by the end of the study.

Results

Patient recruitment began on the 01/05/2012 and is planned to be completed by the 30/04/2013. Recruitment for general practices was completed on 31/10/2012, by which time the target of 36 practices had been recruited. The main trial results will be published in a peer-reviewed journal.

Conclusion

The data from the trial will provide evidence on the effectiveness and cost-effectiveness of collaborative care for depression in people with diabetes and/or coronary heart disease.

Trial registration

Trial registration number: ISRCTN80309252

【 授权许可】

   
2013 Coventry et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Coventry PA, Lovell K, Dickens C, Bower P, Chew-Graham C, Cherrington C, Garrett C, Gibbons CJ, Baguley C, Roughley K, Adeyemi I, Keyworth C, Waheed W, Hann M, Davies L, Jeeva F, Roberts C, Knowles S, Gask L: Collaborative interventions for circulation and depression (COINCIDE): study protocol for a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease. Trials 2012, 13:139. BioMed Central Full Text
• [2]Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Haase AM, Taylor AH, Fox KR, Costelloe C, Searle A, Baxter H, Winder R, Wright C, Turner KM, Calnan M, Lawlor DA, Peters TJ, Sharp DJ, Montgomery AA, Lewis G: Facilitated physical activity as a treatment for depressed adults: randomised controlled trial. BMJ 2012, 344:e2758.
• [3]Medical Research Council: Guidelines for Good Clinical Practice. London: Medical Research Council; 1998.