A Couple-Based Intervention for Chinese Older Adults with Type 2 Diabetes: A Randomized Clinical Trial
Report on the Management of Chinese Older Adults with Type 2 Diabetes through Couple-Based Interventions: A Randomized Clinical Trial
Academic Background
Type 2 Diabetes Mellitus (T2DM) is one of the most prevalent chronic diseases globally, particularly common among older adults. China has the largest number of diabetes patients worldwide, reaching approximately 141 million cases in 2021, over 90% of which comprise Type 2 Diabetes. Despite the Chinese government leveraging community healthcare services to control and address diabetes, management, treatment, and control rates remain relatively low at less than 37%, 33%, and 50%, respectively. This may be attributed to the shortage of trained community healthcare workers and the poor self-management capabilities of older T2DM patients.
Managing diabetes is complex and necessitates constant monitoring. Since daily diabetes management typically takes place within a family context, recent studies and clinical guidelines underscore the key role played by family members—especially spouses—in diabetes care. While spousal involvement in diabetes management is suggested in behavioral theories, evidence from Randomized Clinical Trials (RCTs) remains inconclusive. Most RCTs lack control groups based on individual interventions and primarily report behavioral and psychological outcomes, with insufficient clinical outcome data. Consequently, this study aims to evaluate the impact of couple-based interventions on the health and well-being of Chinese older adults with T2DM and their spouses.
Paper Source
This paper is authored by Conghui Yang, Jingyi Zhi, Yingxin Xu, Xinyu Fan, Xueji Wu, Dong Roman Xu, and Jing Liao. The authors are affiliated with Sun Yat-sen University’s School of Public Health, Sun Yat-sen Global Health Institute, Guangzhou Center for Disease Control and Prevention, and the Southern Medical University Global Health Research Center. The article was published on January 2, 2025, in the JAMA Network Open journal under article ID e2452168.
Study Design and Methods
Study Design
This study is a multi-center RCT designed to compare couple-based interventions with individual-based interventions for older adults with T2DM and their spouses. From September 1, 2020, to June 30, 2022, the study was conducted in 14 community healthcare centers across Guangzhou and involved 207 eligible older adult T2DM patients and their spouses. Participants were randomly assigned to either the couple-based intervention group (106 pairs) or the individual-based control group (101 pairs).
Interventions
Interventions included 4 weekly group education sessions followed by 2 months of behavioral change telephone follow-up. The couple-based intervention group targeted both patients and spouses, while the control group targeted patients only. Educational topics were based on T2DM management guidelines, covering diabetes and its complications, healthy dietary habits, medication management, exercise, and behavior change techniques.
Data Collection and Analysis
The primary outcome measures were HbA1c levels for patients and quality of life for spouses. Secondary outcomes included collective efficacy (shared confidence in managing diabetes) and behavior change among both patients and spouses. Data analysis utilized a multilevel modeling approach, adopting an Intention-to-Treat (ITT) framework for intergroup comparisons.
Study Results
Key Findings
Over the 12-month follow-up, HbA1c levels declined in both groups, but no significant differences were observed between the couple-based and individual-based intervention groups (β = -0.08; 95% CI, -0.57 to 0.42). Patients demonstrated improvements in collective efficacy and behavior following the intervention, yet the magnitude of changes was similar across groups. Spouses showed no significant differences in quality of life between the two groups.
Subgroup Analysis
For patients with higher baseline HbA1c levels (≥8.0%), the couple-based intervention led to more significant and sustained improvements in HbA1c levels compared to those with better glycemic control at baseline (HbA1c <8.0%).
Conclusions and Implications
The study concludes that while couple-based interventions demonstrated weak overall effects, they significantly benefitted older adults with poorly controlled glycemia. Findings suggest that diabetes management strategies for the elderly should account for baseline glycemic levels, spouses’ capacity to provide support, and couples’ preferences for collaborative diabetes care.
Research Highlights
- Key Discovery: Couple-based interventions provided notable and lasting benefits to patients with inadequately controlled HbA1c levels.
- Methodological Innovation: Through multi-center RCT design, interdisciplinary educational integration, and behavioral change components, the study advances the understanding of spousal roles in diabetes management.
- Practical Relevance: Results emphasize the potential of spousal involvement in creating personalized diabetes management strategies for older adults.
Study Limitations
- Participant Heterogeneity: Participants displayed significant variability in HbA1c levels, potentially hindering detectable intergroup differences.
- Reporting Bias: Metrics on collective efficacy and behavior relied on self-reported data, potentially introducing bias.
- Intervention Implementation: Certain limitations, such as lower-than-anticipated attendance rates and COVID-19 lockdown policies, affected the execution of the study.
Future Research Directions
Future studies should involve larger sample sizes in multi-center trials to validate the effects of couple-based interventions. Additionally, tailored diabetes management programs should consider both patient-specific conditions and spousal preferences for involvement.
Detailed results and discussion are available in the JAMA Network Open journal. The full article is open-access for readers, providing further insights into the study methodology and outcomes.