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Chinese Older Adults-Collaboration in Health (COACH)Study (COACH)

Primary Purpose

Depression, Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Collaborations in Health (COACH)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Hypertension, Older Adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tulane University
  • Regents of the University of Michigan
  • University of Rochester Medical Center
  • University of Pennsylvania
  • Zhejiang University
  • Zhejiang Provincial Committee on Aging
  • Zhejiang Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Care as usual

Collaborations in Health (COACH)

Arm Description

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.

Outcomes

Primary Outcome Measures

Depressive symptom change
The measure for depressive symptom change will be the Hamilton Depression Rating Scale.

Secondary Outcome Measures

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.

Full Information

First Posted
September 5, 2013
Last Updated
April 16, 2019
Sponsor
University of Rochester
Collaborators
Zhejiang University, University of Pennsylvania, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01938963
Brief Title
Chinese Older Adults-Collaboration in Health (COACH)Study
Acronym
COACH
Official Title
The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
January 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Zhejiang University, University of Pennsylvania, University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Hypertension
Keywords
Depression, Hypertension, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2685 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
No Intervention
Arm Title
Collaborations in Health (COACH)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborations in Health (COACH)
Intervention Description
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.
Primary Outcome Measure Information:
Title
Depressive symptom change
Description
The measure for depressive symptom change will be the Hamilton Depression Rating Scale.
Time Frame
baseline, 3-, 6-, and 12-month follow up
Secondary Outcome Measure Information:
Title
Adherence to antidepressant and antihypertensive medication recommendations
Description
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.
Time Frame
baseline, 3-, 6-, 9-, and 12-month follow up
Other Pre-specified Outcome Measures:
Title
Hypertension
Description
Blood pressure readings will be taken at baseline and at follow-ups.
Time Frame
baseline, 3-, 6-, 9-, and 12-month follow-up
Title
Health related quality of life
Description
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.
Time Frame
baseline, 3-, 6-, 9-, and 12-month follow up
Title
Costs associated with the intervention
Description
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.
Time Frame
baseline, 3-, 6-, 9-, and 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeates Conwell, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shulin Chen, MD, PhD
Organizational Affiliation
Zhejiang University, Department of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2709
Country
United States
Facility Name
Regents of the University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-1274
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-6205
Country
United States
Facility Name
Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China
Facility Name
Zhejiang Provincial Committee on Aging
City
Hangzhou
ZIP/Postal Code
310007
Country
China
Facility Name
Zhejiang Provincial Center for Disease Control and Prevention
City
Hangzhou
ZIP/Postal Code
310051
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
12748199
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. Erratum In: JAMA. 2003 Jul 9;290(2):197.
Results Reference
background
PubMed Identifier
36279299
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.
Results Reference
derived
PubMed Identifier
29843644
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.
Results Reference
derived

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Chinese Older Adults-Collaboration in Health (COACH)Study

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