Chinese Older Adults-Collaboration in Health (COACH)Study

Not Applicable

Completed

• Conditions: Hypertension; Depression
• Interventions: Behavioral: Collaborations in Health (COACH)

• Registration Number: NCT01938963
• Lead Sponsor: University of Rochester

Brief Summary

This study will see if education of village doctors and aging workers in identification and management of hypertension and depression, using standardized procedures,consultation with a psychiatrist as needed, and collaborations between the village doctor and aging worker in care elderly patients in the village better achieve better outcomes for their depression and high blood pressure than usual care.

Detailed Description

The Depression/Hypertension in Chinese Older Adults - Collaborations in Health (COACH) Study is a randomized controlled trial (RCT) comparing the COACH intervention to care as usual (CAU) for the treatment of comorbid depression and hypertension (HTN) in Chinese older adult rural village residents. COACH integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW; a lay member of the village's Aging Association), supervised by a psychiatrist consultant. Based on chronic disease management principles, the PCP is trained to use evidence based practice guidelines for treatment of both HTN and depression, and provided with access to mental health consultation regarding optimal management of the patient's depression. The AW is trained to conduct a systematic assessment of the older person's social context to identify and reduce social and environmental barriers to treatment adherence and response. AWs participate with the PCP in developing multidisciplinary care plans for their shared patients, reinforce treatment adherence and adoption of healthy behaviors, and emphasize activation and engagement of the older person in activities designed to improve their connectedness to others and to the community. Finally, PCP, AW, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.

One hundred and sixty villages will be randomized to deliver COACH or CAU to eligible subjects who reside there (approximately 15 per village will meet criteria), or a total of about 2400 subjects. Treatment will continue for one year, with research evaluations at baseline, 3 6, 9, and 12 months.

Specific aims of the study are to determine whether COACH is more effective than CAU in treating depression (Aim 1) and HTN (Aim 2); whether improvements in treatment adherence precede reductions in depression and improvement in BP control (Aim 3a), and whether improvements in depression symptoms precede improvements in BP control (Aim 3b); if COACH is associated with greater improvements in health related quality of life than CAU (Aim 4); and to compare the costs associated with each approach (Aim 5).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-10
• Study Start: 2014-01
• Primary Completion: 2018-02-09
• Study Completion: 2019-01-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2685

Inclusion Criteria

• Community-dwelling residents registered to the selected village, and thus also registered patients of the village's PCP.
• Age ≥ 60 years, the typical retirement age in rural China.
• Clinically significant depression defined as baseline PHQ-9 score ≥ 10.
• Diagnosis of hypertension
• Intact cognitive functioning (6-Item Screener score <3) to assure ability to participate with the treatment team in management of their conditions.
• Capable of independent communication
• Capacity to give informed consent.

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Exclusion Criteria

• Incapable (no capacity) of giving verbal consent to this study.
• Acute high suicide risk at baseline assessment. Patients assessed to be dangerously suicidal at later assessments will be discontinued from the study, their providers notified, and their safety guaranteed.
• Psychosis, alcoholism. We exclude patients with psychosis or active alcoholism in the past 6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborations in Health (COACH)	Collaborations in Health (COACH)	COACH integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW; a lay member of the village's Aging Association), supervised by a psychiatrist consultant. Based on chronic disease management principles, the PCP is trained to use evidence based practice guidelines for treatment of both HTN and depression, and provided with access to mental health consultation regarding optimal management of the patient's depression. The AW is trained to conduct a systematic assessment of the older person's social context to identify and reduce social and environmental barriers to treatment adherence and response. AWs participate with the PCP in developing multi-disciplinary care plans for their shared patients, reinforce treatment adherence and adoption of healthy behaviors, and emphasize activation and engagement of the older person in activities designed to improve their connectedness to others and to the community.

Primary Outcome Measures

Name	Time	Method
Depressive symptom change	baseline, 3-, 6-, and 12-month follow up	The measure for depressive symptom change will be the Hamilton Depression Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Adherence to antidepressant and antihypertensive medication recommendations	baseline, 3-, 6-, 9-, and 12-month follow up	First, the Morisky Medication Adherence Measure will be used. Secondly, a Medication Possession Ratio will be used-a combination of pill counts and verification of pharmacy refills.

Trial Locations

Locations (7)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Provincial Center for Disease Control and Prevention; 🇨🇳 Hangzhou, China

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Regents of the University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Zhejiang Provincial Committee on Aging; 🇨🇳 Hangzhou, China

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States