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Open Access 01-12-2018 | Study protocol

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

Authors: Qiang Tu, Lily Dongxia Xiao, Shahid Ullah, Jeffrey Fuller, Huiyun Du

Published in: Trials | Issue 1/2018

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.

Available only for authorised users

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Title: Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial
Authors: Qiang Tu
Lily Dongxia Xiao
Shahid Ullah
Jeffrey Fuller
Huiyun Du
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2766-5

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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