Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/06/2006
Date assigned
14/07/2006
Last edited
06/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.peach.unimelb.edu.au

Contact information

Type

Scientific

Primary contact

Prof Doris Young

ORCID ID

Contact details

200 Berkeley Street
Carlton
3053
Australia

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 measures

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

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

http://www.nhmrc.gov.au

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

Results - basic reporting

Publication summary

2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17428318
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24048296

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes