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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01890226
Other study ID # IRB00067447
Secondary ID 1R01MH100467-01
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date January 2019

Study information

Verified date February 2020
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.

This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.


Recruitment information / eligibility

Status Completed
Enrollment 311
Est. completion date January 2019
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- one or more of the following conditions: hyperlipidemia, hypertension, diabetes

- able to give consent

- patient in the behavioral health home

Exclusion Criteria:

- Unable to give consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mobile Personal Health Record App.


Locations

Country Name City State
United States Viewpoint Health & Oakhurst Medical Center Conyers Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Composite Quality Score It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services. Baseline, 12 month post intervention
Secondary Change in Patient Assessment of Chronic Illness Care 20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model. The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling. Baseline, 6 month post intervention, 12 month post intervention
Secondary Change in Patient Activation Measure Assesses a patients' perceived ability to manage their illnesses and their healthcare visits. Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100. Higher scores indicate greater patient activation. Baseline, 6 month post intervention, 12 month post intervention
Secondary Change in Health-related Quality of Life Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life.
The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning.
Baseline, 6 month post intervention, 12 month post intervention
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