Clinical trial NCT02119572: Impact of Peer Support on Diabetes in China
Official title: Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes
Keywords: diabetes,peer support
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

1. type 2 diabetes
2. with voluntary participation and have signed the Patient Informed Consent Sheet
3. reside in stable places during the intervention period

Exclusion Criteria:

1. Patients with reduced life expectancy and unstable mood or major psychiatric conditions
2. suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year
3. enrolling in other research program at present

Primary outcomes:
measure: Change from Baseline HbA1c at 6 months,12 months
timeFrame: baselline,6months,12months
Secondary outcomes:
measure: Change from Baseline blood pressure at 6 months,12 months
timeFrame: baseline,6 months,12months
measure: Change from Baseline months BMI at 6 months,12 months
timeFrame: baseline,6 months,12months
measure: Change from Baseline months blood liquids at 6 months,12 months
timeFrame: baseline,6 months,12months
measure: Change from Baseline months blood glucose at 6 months,12 months
timeFrame: baseline,6 months,12months
measure: Change from baseline in diabetes self-care activities scales at 6 months,12months
timeFrame: baseline,6 months,12months
measure: Change from baseline in depression scales at 6 months,12months
timeFrame: baseline,6 months,12months
measure: Change from baseline in medication adherence scales at 6 months,12months
timeFrame: baseline,6 months,12months
measure: Change from baseline in quality of life scales at 6 months,12months
timeFrame: baseline,6 months,12months
measure: Change from baseline in diabetes self-efficacy scales at 6 months,12months
timeFrame: baseline,6 months,12months
measure: Change from baseline in diabetes knowledge scales at 6 months,12months
timeFrame: baseline,6 months, 12 months
measure: Change from baseline in positive and negative affectivity at 6 months,12months
timeFrame: baseline, 6 months,12months
measure: Change from baseline in events of hypoglycemia at 6 months,12months
timeFrame: baseline,6 months,12months
measure: Change from baseline advanced glycation end products at 6 months,12months
timeFrame: baseline ,6 months,12months
measure: cost
timeFrame: baseline,6 months,12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Liuhe
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Zilin Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Xie 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.