Glucose Metabolism DisordersNCT02119572
Impact of Peer Support on Diabetes in China
A study testing peer support and usual education lectures in people with Glucose Metabolism Disorders and Metabolic Diseases, run by Zhongda Hospital at 1 site in China.
Trial summary
The prevalence of diabetes has been growing rapidly in developing countries causing a devastating economic burden and increasing demands on healthcare systems. Therefore, there is an urgent need to find cost-effective and multi-faceted approach for diabetes care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
- What is being tested?
- peer support and usual education lectures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- with voluntary participation and have signed the Patient Informed Consent Sheet
- reside in stable places during the intervention period
Who cannot join
- Patients with reduced life expectancy and unstable mood or major psychiatric conditions
- suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year
- enrolling in other research program at present
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liuhe
Nanjing, Jiangsu, 210009
Xiu li Ye, Master, 86-25-83272532, yexiuli0703@163.com
Zilin Sun, Dr.
About this study
Official title: Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial
The prevalence of diabetes has been growing rapidly in developing countries causing a devastating economic burden and increasing demands on healthcare systems. Therefore, there is an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer support models provide a potentially low-cost, flexible means that is complimentary to the current existing health care services. Trained peer leaders can become qualified extenders to a formal healthcare system, thereby, assisting with the education delivery and bolstering the efforts of the professional staff. To implement a culturally- specific peer support program and determine whether it is acceptable, cost-effective in China is important. This study aims to implement and evaluate biophysical and psychosocial outcomes of a peer support program and to explore it's feasibility and sustainability in China
- Being tested
- peer support, usual education lectures
- Keywords
- diabetes,peer support
- Medical subject headings
- Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer supportBehavioural
Also called peer education, peer coach
usual education lecturesOther
| Study group | Role | What they receive |
|---|---|---|
| peer support | Experimental | Patients are divided into small groups and assigned with peer leaders for twelve months according to their residence. Besides the same training and follow-ups as the control arm, patients from intervention groups are suggested and encouraged to take part in the group activities with the peer leaders per month. And if possible, casual activities (such as phone call, chatting, short message; physical exercise, group member family visiting，going to supermarket together, etc.)are also recommended Receives: Behavioral: peer support; Other: usual education lectures |
| usual education | Active comparator | Patients attend the usual self-management education and communicate with the professionals every two months, getting the information on diabetes diet, exercise, glucose monitor, etc. besides that the group members should attend three follow ups at baseline,6 and 12 months. Receives: Other: usual education lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline HbA1c at 6 months,12 months
Measured: baselline,6months,12months
Secondary outcomes (14)
Change from Baseline blood pressure at 6 months,12 months
Measured: baseline,6 months,12months
Change from Baseline months BMI at 6 months,12 months
Measured: baseline,6 months,12months
Change from Baseline months blood liquids at 6 months,12 months
Measured: baseline,6 months,12months
Change from Baseline months blood glucose at 6 months,12 months
Measured: baseline,6 months,12months
Change from baseline in diabetes self-care activities scales at 6 months,12months
Measured: baseline,6 months,12months
Change from baseline in depression scales at 6 months,12months
Measured: baseline,6 months,12months
Change from baseline in medication adherence scales at 6 months,12months
Measured: baseline,6 months,12months
Change from baseline in quality of life scales at 6 months,12months
Measured: baseline,6 months,12months
Change from baseline in diabetes self-efficacy scales at 6 months,12months
Measured: baseline,6 months,12months
Change from baseline in diabetes knowledge scales at 6 months,12months
Measured: baseline,6 months, 12 months
Change from baseline in positive and negative affectivity at 6 months,12months
Measured: baseline, 6 months,12months
Change from baseline in events of hypoglycemia at 6 months,12months
Measured: baseline,6 months,12months
Change from baseline advanced glycation end products at 6 months,12months
Measured: baseline ,6 months,12months
cost
Measured: baseline,6 months,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilin Sun, Zhongda Hospital
- Investigators
- Zilin Sun, Dr., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119572
- Sponsor's protocol ID
- Zhongdaendo1
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ju C, Shi R, Yao L, Ye X, Jia M, Han J, Yang T, Lu Q, Jin H, Cai X, Yuan S, Xie B, Yu X, Coufal MM, Fisher EB, Sun Z. Effect of peer support on diabetes distress: a cluster randomized controlled trial. Diabet Med. 2018 Jun;35(6):770-775. doi: 10.1111/dme.13625. Epub 2018 Apr 11.
PubMed 29574995Xie B, Ye XL, Sun ZL, Jia M, Jin H, Ju CP, Yao L, De Vladmir CH, Yang Y. Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial. BMC Public Health. 2014 Jul 23;14:747. doi: 10.1186/1471-2458-14-747.
PubMed 25056813
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02119572
- Acronym / sponsor ID
- Zhongdaendo1
- Keywords
- diabetes,peer support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Primary completion
- Dec 2016 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of diabetes has been growing rapidly in developing countries causing a devastating economic burden and increasing demands on healthcare systems. Therefore, there is an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer support models provide a potentially low-cost, flexible means that is complimentary to the current existing health care services. Trained peer leaders can become qualified extenders to a formal healthcare system, thereby, assisting with the education delivery and bolstering the efforts of the professional staff. To implement a culturally- specific peer support program and determine whether it is acceptable, cost-effective in China is important. This study aims to implement and evaluate biophysical and psychosocial outcomes of a peer support program and to explore it's feasibility and sustainability in China
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peer support | Experimental | Behavioral: peer support, Other: usual education lecturesPatients are divided into small groups and assigned with peer leaders for twelve months according to their residence. Besides the same training and follow-ups as the control arm, patients from intervention groups are suggested and encouraged to take part in the group activities with the peer leaders per month. And if possible, casual activities (such as phone call, chatting, short message; physical exercise, group member family visiting，going to supermarket together, etc.)are also recommended |
| usual education | Active comparator | Other: usual education lecturesPatients attend the usual self-management education and communicate with the professionals every two months, getting the information on diabetes diet, exercise, glucose monitor, etc. besides that the group members should attend three follow ups at baseline,6 and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes
- with voluntary participation and have signed the Patient Informed Consent Sheet
- reside in stable places during the intervention period
Key exclusion criteria (3 listed)
- Patients with reduced life expectancy and unstable mood or major psychiatric conditions
- suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year
- enrolling in other research program at present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peer supportAlso: peer education, peer coach | Behavioural | peer support |
| usual education lectures | Other | peer support, usual education |
Primary outcome
Change from Baseline HbA1c at 6 months,12 months
Time frame: baselline,6months,12months
14 secondary outcomes
Change from Baseline blood pressure at 6 months,12 months
Time frame: baseline,6 months,12months
Change from Baseline months BMI at 6 months,12 months
Time frame: baseline,6 months,12months
Change from Baseline months blood liquids at 6 months,12 months
Time frame: baseline,6 months,12months
Change from Baseline months blood glucose at 6 months,12 months
Time frame: baseline,6 months,12months
Change from baseline in diabetes self-care activities scales at 6 months,12months
Time frame: baseline,6 months,12months
Change from baseline in depression scales at 6 months,12months
Time frame: baseline,6 months,12months
Change from baseline in medication adherence scales at 6 months,12months
Time frame: baseline,6 months,12months
Change from baseline in quality of life scales at 6 months,12months
Time frame: baseline,6 months,12months
Change from baseline in diabetes self-efficacy scales at 6 months,12months
Time frame: baseline,6 months,12months
Change from baseline in diabetes knowledge scales at 6 months,12months
Time frame: baseline,6 months, 12 months
Change from baseline in positive and negative affectivity at 6 months,12months
Time frame: baseline, 6 months,12months
Change from baseline in events of hypoglycemia at 6 months,12months
Time frame: baseline,6 months,12months
Change from baseline advanced glycation end products at 6 months,12months
Time frame: baseline ,6 months,12months
cost
Time frame: baseline,6 months,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Derived from this study: PubMed 29574995Ju C, Shi R, Yao L, Ye X, Jia M, Han J, Yang T, Lu Q, Jin H, Cai X, Yuan S, Xie B, Yu X, Coufal MM, Fisher EB, Sun Z. Effect of peer support on diabetes distress: a cluster randomized controlled trial. Diabet Med. 2018 Jun;35(6):770-775. doi: 10.1111/dme.13625. Epub 2018 Apr 11.
- Derived from this study: PubMed 25056813Xie B, Ye XL, Sun ZL, Jia M, Jin H, Ju CP, Yao L, De Vladmir CH, Yang Y. Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial. BMC Public Health. 2014 Jul 23;14:747. doi: 10.1186/1471-2458-14-747.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zilin Sun, Dr. principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer support and usual education lectures in people with Glucose Metabolism Disorders and Metabolic Diseases, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Xie, MPH (86-25-83272526, boxxie80@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HbA1c at 6 months,12 months (time frame: baselline,6months,12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.