Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study

Shulin Chen, Yeates Conwell, Jiang Xue, Lydia W Li, Wan Tang, Hillary R Bogner, Hengjin Dong, Shulin Chen, Yeates Conwell, Jiang Xue, Lydia W Li, Wan Tang, Hillary R Bogner, Hengjin Dong

Abstract

Background: Depression and hypertension are common, costly, and destructive conditions among the rapidly aging population of China. The two disorders commonly coexist and are poorly recognized and inadequately treated, especially in rural areas.

Methods: The Chinese Older Adult Collaborations in Health (COACH) Study is a cluster randomized controlled trial (RCT) designed to test the hypotheses that the COACH intervention, designed to manage comorbid depression and hypertension in older adult, rural Chinese primary care patients, will result in better treatment adherence and greater improvement in depressive symptoms and blood pressure control, and better quality of life, than enhanced Care-as-Usual (eCAU). Based on chronic disease management and collaborative care principles, the COACH model integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW) from the village's Aging Association, supervised by a psychiatrist consultant. One hundred sixty villages, each of which is served by one PCP, will be randomly selected from two counties in Zhejiang Province and assigned to deliver eCAU or the COACH intervention. Approximately 2400 older adult residents from the selected villages who have both clinically significant depressive symptoms and a diagnosis of hypertension will be recruited into the study, randomized by the villages in which they live and receive primary care. After giving informed consent, they will undergo a baseline research evaluation; receive treatment for 12 months with the approach to which their village was assigned; and be re-evaluated at 3, 6, 9, and 12 months after entry. Depression and HTN control are the primary outcomes. Treatment received, health care utilization, and cost data will be obtained from the subjects' electronic medical records (EMR) and used to assess adherence to care recommendations and, in a preliminary manner, to establish cost and cost effectiveness of the intervention.

Discussion: The COACH intervention is designed to serve as a model for primary care-based management of common mental disorders that occur in tandem with common chronic conditions of later life. It leverages existing resources in rural settings, integrates social interventions with the medical model, and is consistent with the cultural context of rural life.

Trial registration: ClinicalTrials.gov ID: NCT01938963 ; First posted: September 10, 2013.

Keywords: Collaborative care; Depression; Hypertension; Older adults; Rural China.

Conflict of interest statement

Ethics approval and consent to participate

This protocol received ethics approval from the study’s funding body, the U.S. National Institutes of Health (NIH) Institutional Review Board (IRB). As well, the study protocol was reviewed and approved by the Research Subjects Review Board (RSRB) at University of Rochester, the Health Sciences REB at the Zhejiang University, the Health Sciences IRB at the University of Michigan, and the Health Sciences IRB at the University of Pennsylvania. Subjects all will provide written informed consent to participate in the study.

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.

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