Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
359355
Study information
Scientific title
Patient Engagement And Coaching for Health: an intensive treatment intervention for patients with poorly controlled type 2 diabetes - a cluster randomised controlled trial
Acronym
PEACH
Study hypothesis
1. Are health outcome measures for patients with type 2 diabetes (T2D) from a community improved through access to a patient-focused method for intensive disease self-management (the COACH Program) in the general practice setting, in comparison with usual general practitioner (GP) care only?
2. What is the cost of this intervention and is it likely to be cost-effective in reducing morbidity and mortality?
3. What are the barriers and facilitators of this intensive treatment intervention in general practice in a community?
Please note that extensive amendments have been made to this trial record as of 06/02/2009. They include the following:
1. Scientific title has been added
2. The anticipated end date of this trial has been updated from 31/10/2008 to 31/03/2009
3. The target number of participants has been updated from "608 patients from 32 general practices" to "336 patients from 56 practices"
All other changes are recorded in the relevant fields.
2008 results of a focus group study (phase 1 of the PEACH Study) undertaken prior to the randomised controlled trial (phase 2) can be found at http://www.ncbi.nlm.nih.gov/pubmed/18928555
Ethics approval
University of Melbourne Ethics Committee, approved on 09/05/2006 (ref: 060123)
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes with HbA1C >7.5% in the last 12 months
Intervention
Intervention group: will receive telephone coaching sessions from existing practice nurses over an 18-month period. The telephone coaching session is a patient-centred program for disease self-management (COACH program), tailored to achieve intensive, multifactorial diabetes treatment. Monitoring rates and process of care, as well as clinical and laboratory indicators will be measured at baseline,12, and 18 months.
Control group: will only receive usual care from their GPs.
The telephone coaching session is a patient-centred program for disease self-management (COACH Program), tailored to achieve intensive, nultifactorial diabetes treatment. Monitoring rates and process of care, as well as clinical and laboratory indicators will be measured at baseline, at 12 and 18 months
As of 06/02/2009: Recruitment completed. Currently completing 12 and 18 months follow up.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The change in HbA1c level from baseline to 12 and 18 months post-randomisation in the intervention group compared with the control group
Secondary outcome measures
Comparative change from baseline to follow-up of:
1. Process of GP care measures
2. Diabetes therapy
3. Antihypertensive therapy
4. Statin therapy
5. Aspirin therapy
6. Total cholesterol, triglyceride, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol levels, urinary albumin, blood pressure, body mass index, quality of life, diabetes self-efficacy, depression, and cost-effectiveness
Added as of 06/02/2009: Follow-up assessments will be carried out at 12 and 18 months post-baseline assessments
Overall trial start date
01/08/2006
Overall trial end date
31/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 06/02/2009:
1. General practices will be included in the study if practices are computerised
2. >50% of Practice GPs agree to participate and to be randomised to intervention or control group
3. GPs are willing to search their medical records and pathology database with assistance from research team and be willing to recruit patients with T2D from their practices in accordance with privacy and ethical guidelines
4. Patients with T2D will be invited to participate if they are >18 years with haemoglobin HbA1c (HbA1c) >7.5% and receiving care from general practices in the northern or northwest region of Melbourne that employ a practice nurse.
Previous inclusion criteria:
1. General practices will be included in the study if practices are computerised
2. >50% of Practice GPs agree to participate and to be randomised to intervention or control group
3. GPs are willing to search their medical records database with assistance from research team and be willing to recruit patients with T2D from their practices in accordance with privacy and ethical guidelines
4. Patients with T2D will be invited to participate if they are >18 years with haemoglobin HbA1c (HbA1c) >7.5% and receiving care from general practices in the northern or northwest region of Melbourne that employ a practice nurse.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
336 patients from 56 practices
Participant exclusion criteria
1. Patients will be excluded if they are not contactable by telephone
2. Patients having a complex debilitating coexisting medical condition e.g. mental illness, end-stage cancer
3. Patients who do not provide signed consent
Recruitment start date
01/08/2006
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Australia
Trial participating centre
200 Berkeley Street
Carlton
3053
Australia
Sponsor information
Organisation
National Health and Medical Research Council (Australia)
Sponsor details
MDP 33
GPO Box 9848
Canberra
2601
Australia
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (Australia) - GP Clinical Research Grant (ref: 359355)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17428318
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24048296
Publication citations
-
Protocol
Young D, Furler J, Vale M, Walker C, Segal L, Dunning P, Best J, Blackberry I, Audehm R, Sulaiman N, Dunbar J, Chondros P, 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 Fam Pract, 2007, 8, 20, doi: 10.1186/1471-2296-8-20.
-
Results
Blackberry ID, Furler JS, Best JD, Chondros P, Vale M, Walker C, Dunning T, Segal L, Dunbar J, Audehm R, Liew D, Young D, Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial., BMJ, 2013, 347, f5272.