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Development and Validation of Couple-based Collaborative Management Model of Type 2 Diabetes Mellitus for Community-Dwelling Older Adults in China:protocol for a hybrid type 1 randomized controlled trial

Development and Validation of Couple-based Collaborative Management Model of Type 2 Diabetes Mellitus for Community-Dwelling Older Adults in China:protocol for a hybrid type 1 randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027137
Enrollment
Unknown
Registered
2019-11-01
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Experimental group:Couple-based diabetes education and training, behavior change booster, behavior change incentive
control arm:Patient-based diabetes education and training
Control group:Patient-based behavior change booster, behavior change incentive

Sponsors

School of Public Health, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. confirmed T2DM patients who registered for the National Essential Public Health Services for T2DM Management; 2. with the latest fasting blood glucose level >8.0 mmol/L or the latest glycosylated hemoglobin >7.0% or newly diagnosed T2DM during the past 12 months; 3. aged >=55 years; 4. with basic literacy, adequate cognitive and physical capability; 5. living with spouses; 6. willing to provide informed consent to participate in the study. Eligible spouses are these (1) married or cohabitate with a T2DM patient; (2) without mental or physical dysfunctions that may interfere with the study; (3) willing to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who previously participated in T2DM education courses; 2. We further exclude couples that both have diabetes, for a clear distinction between patients and spouses.

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin;quality of life;

Secondary

MeasureTime frame
management behaviours;Physical activity;Dietary Intake;Medication Adherence;blood pressure;waist circumstance;Body Mass Index (BMI);fasting glucose;lipid;

Countries

China

Contacts

Public ContactJing Liao

Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University

liaojing5@sysu.edu.cn13560339049

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026