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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

Tracking Information
First Submitted Date  ICMJE September 5, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date February 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2013)
  • Hypertension [ Time Frame: baseline, 3-, 6-, 9-, and 12-month follow-up ]
    Blood pressure readings will be taken at baseline and at follow-ups.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Chinese Older Adults-Collaboration in Health (COACH)Study
Official Title  ICMJE The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Hypertension
Intervention  ICMJE Behavioral: Collaborations in Health (COACH)
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Collaborations in Health (COACH)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2018)
2685
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
2400
Actual Study Completion Date  ICMJE January 2, 2019
Actual Primary Completion Date February 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938963
Other Study ID Numbers  ICMJE R01MH100298-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yeates Conwell, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE
  • Zhejiang University
  • University of Pennsylvania
  • University of Michigan
Investigators  ICMJE
Principal Investigator: Yeates Conwell, MD University of Rochester
Principal Investigator: Shulin Chen, MD, PhD Zhejiang University, Department of Psychology
PRS Account University of Rochester
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP