Hypertension Clinical Trial
Official title:
A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers
Individuals with serious mental illnesses (SMI) face high rates of medical comorbidity as well as challenges in managing these conditions. A growing workforce of certified peer specialists is available to help these individuals more effectively manage their health and health care. However, there is little existing research examining the effectiveness of peer-led medical self-management programs for this population. in this trial, participants were randomized to either the Health and Recovery Peer program (HARP), a medical disease self-management program led by certified peer specialists, or to care as usual. Assessments were conducted at baseline, 3 months, and 6 months.
Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and
also challenges in effectively managing these health problems. There is an urgent need to
develop self-management strategies that allow persons with SMI to more effectively manage
their chronic medical illnesses.
In general populations, peer-led disease self-management interventions have been demonstrated
to be feasible, effective, scalable, and to lead to sustainable improvements in
self-management and health outcomes. With funding from an R34 intervention development grant
from NIMH, the study team has developed and piloted a modified version of the most widely
tested and used peer-led self management program, the Chronic Disease Self-Management Program
(CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the
Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented
with high engagement, retention, and program fidelity, and can result in effect sizes across
a range of outcomes comparable to or greater than those seen in general medical populations.
This application proposes to conduct a fully-powered, multisite trial of the HARP program. A
total of 400 individuals with serious mental illnesses and one or more chronic medical
condition will be recruited from three diverse community mental health clinics in the Atlanta
metro region and randomized to the HARP program or usual care. For individuals in the HARP
program, two peer educators with SMI and one or more chronic medical condition will lead a
six-session, six-week manualized intervention, which helps participants become more effective
managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6
months and one year will assess changes in clinical outcomes, improvement in generic and
disease-specific measures of illness self-management, and quality of care. During the final
phase of the study, a dissemination strategy building on the CDSMP training infrastructure
will allow program participants to lead HARP groups.
This study will establish the first fully peer-led, evidence-based intervention for improving
physical self-management in this vulnerable population.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |