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

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ClinicalTrials.gov Identifier: NCT01938963
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Zhejiang University
University of Pennsylvania
University of Michigan
Information provided by (Responsible Party):
Yeates Conwell, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Depression Hypertension Behavioral: Collaborations in Health (COACH) Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2685 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
Study Start Date : January 2014
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Care as usual
Experimental: 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.
Behavioral: Collaborations in Health (COACH)
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.




Primary Outcome Measures :
  1. Depressive symptom change [ Time Frame: baseline, 3-, 6-, and 12-month follow up ]
    The measure for depressive symptom change will be the Hamilton Depression Rating Scale.


Secondary Outcome Measures :
  1. Adherence to antidepressant and antihypertensive medication recommendations [ Time Frame: baseline, 3-, 6-, 9-, and 12-month follow up ]
    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.


Other Outcome Measures:
  1. Hypertension [ Time Frame: baseline, 3-, 6-, 9-, and 12-month follow-up ]
    Blood pressure readings will be taken at baseline and at follow-ups.

  2. Health related quality of life [ Time Frame: baseline, 3-, 6-, 9-, and 12-month follow up ]

    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.


  3. Costs associated with the intervention [ Time Frame: baseline, 3-, 6-, 9-, and 12-month follow-up ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938963


Locations
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United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112-2709
United States, Michigan
Regents of the University of Michigan
Ann Arbor, Michigan, United States, 48109-1274
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6205
China, Zhejiang
Zhejiang University
Hangzhou, Zhejiang, China, 310058
China
Zhejiang Provincial Committee on Aging
Hangzhou, China, 310007
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, China, 310051
Sponsors and Collaborators
University of Rochester
Zhejiang University
University of Pennsylvania
University of Michigan
Investigators
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Principal Investigator: Yeates Conwell, MD University of Rochester
Principal Investigator: Shulin Chen, MD, PhD Zhejiang University, Department of Psychology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yeates Conwell, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01938963     History of Changes
Other Study ID Numbers: R01MH100298-01 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Keywords provided by Yeates Conwell, University of Rochester:
Depression
Hypertension
Older Adults

Additional relevant MeSH terms:
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Hypertension
Depression
Depressive Disorder
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders