NCT01938963

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,685

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable depression

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4.1 years

First QC Date

September 5, 2013

Last Update Submit

April 16, 2019

Conditions

DepressionHypertension

Keywords

DepressionHypertensionOlder Adults

Outcome Measures

Primary Outcomes (1)

  • Depressive symptom change

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

    baseline, 3-, 6-, and 12-month follow up

Secondary Outcomes (1)

  • Adherence to antidepressant and antihypertensive medication recommendations

    baseline, 3-, 6-, 9-, and 12-month follow up

Other Outcomes (3)

  • Hypertension

    baseline, 3-, 6-, 9-, and 12-month follow-up

  • Health related quality of life

    baseline, 3-, 6-, 9-, and 12-month follow up

  • Costs associated with the intervention

    baseline, 3-, 6-, 9-, and 12-month follow-up

Study Arms (2)

Care as usual

NO INTERVENTION

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.

Behavioral: Collaborations in Health (COACH)

Interventions

Collaborations in Health (COACH)BEHAVIORAL

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

Collaborations in Health (COACH)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Tulane University

New Orleans, Louisiana, 70112-2709, United States

Location

Regents of the University of Michigan

Ann Arbor, Michigan, 48109-1274, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6205, United States

Location

Zhejiang University

Hangzhou, Zhejiang, 310058, China

Location

Zhejiang Provincial Committee on Aging

Hangzhou, 310007, China

Location

Zhejiang Provincial Center for Disease Control and Prevention

Hangzhou, 310051, China

Location

Related Publications (3)

  • 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.

    PMID: 12748199BACKGROUND

  • 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.

    PMID: 36279299DERIVED

  • 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.

    PMID: 29843644DERIVED

MeSH Terms

Conditions

DepressionHypertension

Interventions

Health

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Yeates Conwell, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Shulin Chen, MD, PhD

    Zhejiang University, Department of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

January 1, 2014

Primary Completion

February 9, 2018

Study Completion

January 2, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

CN(3)US(4)