Clinical trial NCT01938963: Chinese Older Adults-Collaboration in Health (COACH)Study
Official title: The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Hypertension
Keywords: Depression
Hypertension
Older Adults
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: University of Pennsylvania
name: University of Michigan
First posted: 2013-09-10
Enrollment: 2685
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Depressive symptom change
timeFrame: baseline, 3-, 6-, and 12-month follow up
Secondary outcomes:
measure: Adherence to antidepressant and antihypertensive medication recommendations
timeFrame: baseline, 3-, 6-, 9-, and 12-month follow up
Other outcomes:
measure: Hypertension
timeFrame: baseline, 3-, 6-, 9-, and 12-month follow-up
measure: Health related quality of life
timeFrame: baseline, 3-, 6-, 9-, and 12-month follow up
measure: Costs associated with the intervention
timeFrame: baseline, 3-, 6-, 9-, and 12-month follow-up
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Ann Arbor
country: United States
facility: Regents of the University of Michigan
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Committee on Aging
city: Hangzhou
country: China
facility: Zhejiang Provincial Center for Disease Control and Prevention
Study officials:
affiliation: University of Rochester
name: Yeates Conwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University, Department of Psychology
name: Shulin Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.