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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| University of Pennsylvania | OTHER |
| University of Michigan | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care as usual | No Intervention | ||
| Collaborations in Health (COACH) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborations in Health (COACH) | Behavioral | Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptom change | The measure for depressive symptom change will be the Hamilton Depression Rating Scale. | baseline, 3-, 6-, and 12-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to antidepressant and antihypertensive medication recommendations | 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. | baseline, 3-, 6-, 9-, and 12-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension | Blood pressure readings will be taken at baseline and at follow-ups. | baseline, 3-, 6-, 9-, and 12-month follow-up |
| Health related quality of life | Quality of life will be measured using the World Health Organization Quality of Life- short version, WHOQOL-BREF. Satisfaction will be measured with the Client Satisfaction Questionnaire 8-item. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yeates Conwell, MD | University of Rochester | Principal Investigator |
| Shulin Chen, MD, PhD | Zhejiang University, Department of Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112-2709 | United States | ||
| Regents of the University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12748199 | Background | 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. | |
| 36279299 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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| baseline, 3-, 6-, 9-, and 12-month follow up |
| Costs associated with the intervention | Two components will be evaluated: program costs associated with adding resources to care as usual, and medical costs attributed to the care of the subjects in each arm. | baseline, 3-, 6-, 9-, and 12-month follow-up |
| Ann Arbor |
| Michigan |
| 48109-1274 |
| United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-6205 | United States |
| Zhejiang University | Hangzhou | Zhejiang | 310058 | China |
| Zhejiang Provincial Committee on Aging | Hangzhou | 310007 | China |
| Zhejiang Provincial Center for Disease Control and Prevention | Hangzhou | 310051 | China |
| Derived |
| 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. |
| 29843644 | Derived | 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. |