DepressionCOACHNCT01938963
Chinese Older Adults-Collaboration in Health (COACH)Study
A study testing Collaborations in Health (COACH) in people with Depression and Hypertension, run by University of Rochester at 7 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Hypertension
- What is being tested?
- Collaborations in Health (COACH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,685 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2014to 2 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Regents of the University of Michigan
Ann Arbor, Michigan, 48109-1274
Tulane University
New Orleans, Louisiana, 70112-2709
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6205
University of Rochester Medical Center
Rochester, New York, 14642
China3 sites
Zhejiang University
Hangzhou, Zhejiang, 310058
Zhejiang Provincial Committee on Aging
Hangzhou, 310007
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, 310051
About this study
Official title: The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
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.
Read the 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).
- Conditions
- Depression, Hypertension
- Being tested
- Collaborations in Health (COACH)
- Keywords
- Depression, Hypertension, Older Adults
- Medical subject headings
- Depression, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborations in Health (COACH)Behavioural
Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Not described |
| Collaborations in Health (COACH) | Experimental | 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. Receives: Behavioral: Collaborations in Health (COACH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom change
The measure for depressive symptom change will be the Hamilton Depression Rating Scale.
Measured: baseline, 3-, 6-, and 12-month follow up
Secondary outcomes (1)
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.
Measured: baseline, 3-, 6-, 9-, and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJan 2014
- Primary completion9 Feb 2018
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,685 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, University of Pennsylvania, University of Michigan
- Responsible party
- Principal investigator, Yeates Conwell, University of Rochester
- Investigators
- Yeates Conwell, MD, Principal investigator, University of RochesterShulin Chen, MD, PhD, Principal investigator, Zhejiang University, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938963
- Sponsor's protocol ID
- R01MH100298-01
- Acronym
- COACH
- Status last verified
- Apr 2019
- First submitted
- 5 Sep 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12748199Chen 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.
PubMed 36279299Chen 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.
PubMed 29843644
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
- ClinicalTrials.gov ID
- NCT01938963
- Acronym / sponsor ID
- COACH / R01MH100298-01
- Conditions
- Depression, Hypertension
- Keywords
- Depression, Hypertension, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,685 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Zhejiang University, University of Pennsylvania, University of Michigan
- Study start
- Jan 2014
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | – |
| Collaborations in Health (COACH) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborations in Health (COACH)Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care. | Behavioural | Collaborations in Health (COACH) |
Primary outcome
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.
1 secondary outcome
Adherence to antidepressant and antihypertensive medication recommendations
Time frame: baseline, 3-, 6-, 9-, and 12-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 12748199Chobanian 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.
- Derived from this study: PubMed 36279299Chen 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.
- Derived from this study: PubMed 29843644Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeates Conwell, MD principal investigator
University of Rochester
Shulin Chen, MD, PhD principal investigator
Zhejiang University, Department of Psychology
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborations in Health (COACH) in people with Depression and Hypertension, run by University of Rochester at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom change (time frame: baseline, 3-, 6-, and 12-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.