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. 2018 Jul 16;19(1):385.
doi: 10.1186/s13063-018-2766-5.

Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial

Qiang Tu  1 , Lily Dongxia Xiao  2 , Shahid Ullah  3 , Jeffrey Fuller  1 , Huiyun Du  1
Affiliations

Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial

Qiang Tu et al. Trials. .

Abstract

Background: Although China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.

Methods: A cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N = 5) or a usual care group (N = 5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.

Discussion: This study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.

Trial registration: Australia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Keywords: China; Cluster randomized controlled trial; Collaborative care; Diabetes; Hypertension; Primary health system.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by the Southern Adelaide Clinical Human Research Ethics Committee in Australia (Approval Number: 345.16) and the Department of Scientific Research Management at the Health and Family Planning Commission of Jiangxi Province, China. All participants and health professionals delivering the interventions will be given written information so that they can provide informed consent. Each participant and participating health facility will be given a unique numerical code to ensure anonymity. Information provided by participants will be collected in a de-identifiable form and treated confidentially. Data collected through this study will be stored in a secure area in the University that the first author is enrolled in a PhD program. All study-related data will only be accessible to the researchers.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT figure. GP general practitioner, HbA1 glycosylated hemoglobin
Fig. 2
Fig. 2
Timeline diagram
Fig. 3
Fig. 3
Flow chart of the randomization
Fig. 4
Fig. 4
Flow chart of the intervention protocol. BP blood pressure, CHSC community health service center, GP general practitioner
See this image and copyright information in PMC

References

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