Chinese Older Adults-Collaboration in Health (COACH)Study
NCT ID: NCT01938963
Last Updated: 2019-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2685 participants
INTERVENTIONAL
2014-01-31
2019-01-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Care as usual
No interventions assigned to this group
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.
Collaborations in Health (COACH)
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.
Interventions
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Collaborations in Health (COACH)
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
University of Pennsylvania
OTHER
University of Michigan
OTHER
University of Rochester
OTHER
Responsible Party
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Yeates Conwell
Professor
Principal Investigators
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Yeates Conwell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Shulin Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University, Department of Psychology
Locations
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Tulane University
New Orleans, Louisiana, United States
Regents of the University of Michigan
Ann Arbor, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial Committee on Aging
Hangzhou, , China
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, , China
Countries
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References
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Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
Chen S, Conwell Y, Xue J, Li L, Zhao T, Tang W, Bogner H, Dong H. Effectiveness of integrated care for older adults with depression and hypertension in rural China: A cluster randomized controlled trial. PLoS Med. 2022 Oct 24;19(10):e1004019. doi: 10.1371/journal.pmed.1004019. eCollection 2022 Oct.
Chen S, Conwell Y, Xue J, Li LW, Tang W, Bogner HR, Dong H. Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study. BMC Geriatr. 2018 May 29;18(1):124. doi: 10.1186/s12877-018-0808-1.
Other Identifiers
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