An interventional study of Collaborations in Health (COACH) in Depression and Hypertension, sponsored by University of Rochester. Completed at 7 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
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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Exclusion Criteria:
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.
Depressive symptom change
The measure for depressive symptom change will be the Hamilton Depression Rating Scale.
Time frame: baseline, 3-, 6-, and 12-month follow up
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.
Time frame: baseline, 3-, 6-, 9-, and 12-month follow up
Hypertension
Blood pressure readings will be taken at baseline and at follow-ups.
Time frame: baseline, 3-, 6-, 9-, and 12-month follow-up
Health related quality of life
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.
Time frame: baseline, 3-, 6-, 9-, and 12-month follow up
Costs associated with the intervention
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.
Time frame: baseline, 3-, 6-, 9-, and 12-month follow-up
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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