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Trial registered on ANZCTR


Registration number
ACTRN12609000469213
Ethics application status
No
Date submitted
8/06/2009
Date registered
16/06/2009
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A controlled evaluation of the Australasian Peers for Progress Diabetes Program (PfP-DP) and its transferability to other countries.
Scientific title
The impact of the Australasian Peers for Progress-Diabetes Program on glycosylated hemoglobin levels in people with type 2 diabetes compared with a wait-list condition.
Secondary ID [1] 252258 0
nil known
Universal Trial Number (UTN)
Trial acronym
Australasian PfP-DP: Australasian Peers for Progress-Diabetes Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 4869 0
Condition category
Condition code
Metabolic and Endocrine 237220 237220 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will be peer support groups for people with type 2 diabetes, led by lay peer leaders. Groups will meet monthly over a period of 12 months, with each session running for approximately 90 minutes. The sessions will address some of the key steps involved in behaviour change and chronic disease management, including physical activity, medication adherence, nutrition, and smoking cessation.
Intervention code [1] 236651 0
Lifestyle
Comparator / control treatment
The control treatment will be a waitlist condition, who continue with their usual care and management of diabetes then commence the Peer Support program after the 12 month wait.
Control group
Active

Outcomes
Primary outcome [1] 238034 0
Glycosylated Hemoglobin (HbA1c) Levels. This will be assessed through blood analysis.
Timepoint [1] 238034 0
Baseline, 6, 12 and 18 months after commencing peer support
Primary outcome [2] 279459 0
UKPDS Cardiovascular risk score
Timepoint [2] 279459 0
Baseline, 6, 12, and 18 months after commencing peer support
Secondary outcome [1] 242192 0
Quality of Life and Psychosocial Functioning (SF-36 Questionnaire)
Timepoint [1] 242192 0
Baseline, 6, 12 and 18 months after commencing peer support
Secondary outcome [2] 242193 0
Physical Activity (Active Australia Survey)
Timepoint [2] 242193 0
Baseline, 6, 12 and 18 months after commencing peer support
Secondary outcome [3] 242194 0
Medication adherence (Self-reported medication adherence based on Haynes Pill Count and Medication)
Timepoint [3] 242194 0
Baseline, 6, 12 and 18 months after commencing peer support
Secondary outcome [4] 242195 0
Body Mass Index (BMI). This will be calculated by a study nurse/research assistant by measuring height and weight at assessment points.
Timepoint [4] 242195 0
Baseline, 6, 12 and 18 months after commencing peer support
Secondary outcome [5] 242448 0
Nutrition (Cancer Council Food Frequency Questionnaire)
Timepoint [5] 242448 0
Baseline, 6, 12 and 18 months after commencing peer support

Eligibility
Key inclusion criteria
1) Stable diagnosis of Type 2 Diabetes for at least 12 months
2) Ability to give consent
3) Conversational command of english
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to give informed consent
2) A current debilitating medical or related condition (e.g. severe mental illness or endstage cancer)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification by location (rural or urban) prior to simple randomization by using a randomization table created by a computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants will receive the intervention, however not at the same time. The 2nd group will receive the 12 month intervention after the first group has received their 12 month intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
198
Accrual to date
Final
Recruitment outside Australia
Country [1] 237920 0
State/province [1] 237920 0
Country [2] 237922 0
State/province [2] 237922 0
Country [3] 237923 0
State/province [3] 237923 0
Country [4] 237924 0
State/province [4] 237924 0
Country [5] 237925 0
State/province [5] 237925 0
Country [6] 237926 0
State/province [6] 237926 0
Country [7] 237927 0
State/province [7] 237927 0
Country [8] 237928 0
State/province [8] 237928 0
Country [9] 237929 0
State/province [9] 237929 0
Country [10] 237930 0
State/province [10] 237930 0
Country [11] 237931 0
State/province [11] 237931 0
Country [12] 237932 0
State/province [12] 237932 0
Country [13] 237933 0
State/province [13] 237933 0
Country [14] 237934 0
State/province [14] 237934 0
Country [15] 237935 0
State/province [15] 237935 0
Country [16] 237936 0
State/province [16] 237936 0
Country [17] 237937 0
State/province [17] 237937 0
Country [18] 237938 0
State/province [18] 237938 0
Country [19] 237939 0
State/province [19] 237939 0
Country [20] 237940 0
State/province [20] 237940 0
Country [21] 237941 0
State/province [21] 237941 0
Country [22] 237942 0
State/province [22] 237942 0
Country [23] 237943 0
State/province [23] 237943 0
Country [24] 237944 0
State/province [24] 237944 0
Country [25] 237945 0
State/province [25] 237945 0
Country [26] 237946 0
State/province [26] 237946 0
Country [27] 237947 0
State/province [27] 237947 0
Country [28] 237948 0
State/province [28] 237948 0
Country [29] 237949 0
State/province [29] 237949 0
Country [30] 237950 0
State/province [30] 237950 0
Country [31] 237951 0
State/province [31] 237951 0
Country [32] 237952 0
State/province [32] 237952 0
Country [33] 237953 0
State/province [33] 237953 0
Country [34] 237954 0
State/province [34] 237954 0
Country [35] 237955 0
State/province [35] 237955 0
Country [36] 237956 0
State/province [36] 237956 0
Country [37] 237957 0
State/province [37] 237957 0
Country [38] 237958 0
State/province [38] 237958 0
Country [39] 237959 0
State/province [39] 237959 0
Country [40] 237960 0
State/province [40] 237960 0
Country [41] 237961 0
State/province [41] 237961 0
Country [42] 237962 0
State/province [42] 237962 0
Country [43] 237963 0
State/province [43] 237963 0

Funding & Sponsors
Funding source category [1] 5053 0
Charities/Societies/Foundations
Name [1] 5053 0
American Association of Family Physicians Foundation
Country [1] 5053 0
United States of America
Primary sponsor type
Individual
Name
Professor Brian Oldenburg
Address
Department of Epidemiology and Preventive Medicine
Monash University, Alfred Hospital Campus
Level 3, 80 Commercial Road
Melbourne, 3004
VICTORIA
Country
Australia
Secondary sponsor category [1] 4642 0
None
Name [1] 4642 0
Address [1] 4642 0
Country [1] 4642 0
Other collaborator category [1] 684 0
Individual
Name [1] 684 0
Professor James Dunbar
Address [1] 684 0
Flinders and Deakin Universities
PO Box 423
Warrnambool, Victoria
3280
Country [1] 684 0
Australia
Other collaborator category [2] 685 0
Individual
Name [2] 685 0
Professor Prasuna Reddy
Address [2] 685 0
Flinders and Deakin Universities
PO Box 423
Warrnambool, Victoria
3280
Country [2] 685 0
Australia
Other collaborator category [3] 686 0
Individual
Name [3] 686 0
Dr Ralph Audehm
Address [3] 686 0
Diabetes Australia-Victoria
570 Elizabeth Street
Melbourne, Victoria
3000
Country [3] 686 0
Australia
Other collaborator category [4] 687 0
Individual
Name [4] 687 0
Mr Greg Johnson
Address [4] 687 0
570 Elizabeth Street
Melbourne, Victoria
3000
Country [4] 687 0
Australia
Other collaborator category [5] 688 0
Individual
Name [5] 688 0
Associate Professor Maximilian de Courten
Address [5] 688 0
Department of Epidemiology and Preventuve Medicine
Monash University, Alfred Hospital Campus
Level 3, 89 Commercial Road
Melbourne, Victoria
3004
Country [5] 688 0
Australia
Other collaborator category [6] 689 0
Individual
Name [6] 689 0
Associate Professor Rory Wolfe
Address [6] 689 0
Department of Epidemiology and Preventive Medicine
Monash University, Alfred Hospital Campus
Level 3, 89 Commercial Road
Melbourne, 3004
Country [6] 689 0
Australia
Other collaborator category [7] 690 0
Individual
Name [7] 690 0
Professor Rob Carter
Address [7] 690 0
School of Health and Social Development
Deakin University
221 Burwood Highway
Burwood, Victoria
3125
Country [7] 690 0
Australia
Other collaborator category [8] 691 0
Individual
Name [8] 691 0
Dr Pilvikki Absetz
Address [8] 691 0
National Institute of Public Health
Mannerheimintie 166
Helsinki -00300
Country [8] 691 0
Finland
Other collaborator category [9] 692 0
Individual
Name [9] 692 0
Professor Anuar Zaini
Address [9] 692 0
Monash University Malaysia
2, Jalan Kolej, Bandar Sunway
46150 Petaling Jaya
Country [9] 692 0
Malaysia

Ethics approval
Ethics application status
No
Ethics committee name [1] 239222 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 239222 0
Monash Research Office
Building 3d
Monash University
Victoria 3800
Australia
Ethics committee country [1] 239222 0
Australia
Date submitted for ethics approval [1] 239222 0
17/06/2009
Approval date [1] 239222 0
01/01/0001
Ethics approval number [1] 239222 0

Summary
Brief summary
The major goal of this research project is to implement and evaluate a structured state-of-the-art peer-led group program to improve daily management, social and emotional support, linkages to clinical care and ongoing support for people with Type 2 Diabetes Mellitus (T2DM). It seems likely that the benefits of such programs, compared to those delivered exclusively by health professionals, results from features of the social support offered and the connections established with local community resources and other supports.

The evaluation proposal also includes a comprehensive health economic evaluation of the cost-effectiveness of the program as well as its future transferability to other settings and countries in the Asia Pacific Region and Southern Africa. The project could significantly influence the successful implementation of peer-led diabetes management programs across these countries and Australia.

The aims of the trial are:
1. To implement and evaluate the impact of the Australasian Peers for Progress-Diabetes Program (PfP-DP) on diabetes self management, social and emotional support, linkage(s) to clinical care and ongoing support.
2. To evaluate the cost-effectiveness of PfP-DP and its potential long-term benefits and potential transferability to other settings and countries.
3. To identify salient enablers and barriers to future system-wide uptake in Australia and potential transferability to Malaysia and other middle income countries in Asia and Southern Africa.

Hypothesis:
Compared with those in the wait-list control condition, participants in the Australasian PfP-DP will demonstrate significantly greater improvements in HbA1c at 12 months following baseline measurement, and will show improvements in diabetes self-management, social and emotional support, linkages to clinical care and ongoing support.
Trial website
www.peersforprogress.monash.edu.au (under construction)
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided
Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.