Chinese Older Adults-Collaboration in Health (COACH)Study

Hypertension Clinical Trial

— COACH  

Official title:

The Depression/Hypertension in Chinese Older Adults-Collaboration in Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938963
• Other study ID #: R01MH100298-01
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2, 2019

Study information

• Verified date: April 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2685
• Est. completion date: January 2, 2019
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Hypertension

Intervention

Behavioral:
• Collaborations in Health (COACH)
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.

Locations

Country	Name	City	State
China	Zhejiang Provincial Center for Disease Control and Prevention	Hangzhou
China	Zhejiang Provincial Committee on Aging	Hangzhou
China	Zhejiang University	Hangzhou	Zhejiang
United States	Regents of the University of Michigan	Ann Arbor	Michigan
United States	Tulane University	New Orleans	Louisiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	University of Michigan, University of Pennsylvania, Zhejiang University

Countries where clinical trial is conducted

United States,  China, 

References & Publications (1)

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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypertension	Blood pressure readings will be taken at baseline and at follow-ups.	baseline, 3-, 6-, 9-, and 12-month follow-up
Other	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.	baseline, 3-, 6-, 9-, and 12-month follow up
Other	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
Primary	Depressive symptom change	The measure for depressive symptom change will be the Hamilton Depression Rating Scale.	baseline, 3-, 6-, and 12-month follow up
Secondary	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