Patient Engagement And Coaching for Health: an intensive treatment intervention for patients with type 2 diabetes in communities
| ISRCTN | ISRCTN50662837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50662837 |
| Secondary identifying numbers | 359355 |
- Submission date
- 19/06/2006
- Registration date
- 14/07/2006
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Doris Young
Scientific
Scientific
200 Berkeley Street
Carlton
3053
Australia
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 |
| Study acronym | PEACH |
| Study objectives | 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(s) | University of Melbourne Ethics Committee, approved on 09/05/2006 (ref: 060123) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2006 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 336 patients from 56 practices |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Australia
Study participating centre
200 Berkeley Street
Carlton
3053
Australia
3053
Australia
Sponsor information
National Health and Medical Research Council (Australia)
Research council
Research council
MDP 33
GPO Box 9848
Canberra
2601
Australia
| Website | http://www.nhmrc.gov.au |
|---|---|
"ROR" |
https://ror.org/011kf5r70 |
Funders
Funder type
Research council
National Health and Medical Research Council (Australia) - GP Clinical Research Grant (ref: 359355)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/04/2007 | Yes | No | |
| Results article | results | 18/09/2013 | Yes | No |
