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Completed

NCT Number: NCT01938963

Chinese Older Adults-Collaboration in Health (COACH)Study

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang University, Hangzhou, Zhejiang, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collaborations in Health (COACH)

Behavioral

Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • University of Michigan
  • University of Pennsylvania
  • Zhejiang University

Registry information

Official study title

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

Acronym: COACH

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Sep 10, 2013
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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