NCT01890226

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

June 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

June 25, 2013

Results QC Date

January 23, 2020

Last Update Submit

February 4, 2020

Conditions

HypertensionHyperlipidemiaDiabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Patient Assessment of Chronic Illness Care

    Baseline, 6 month post intervention, 12 month post intervention

  • Change in Patient Activation Measure

    Baseline, 6 month post intervention, 12 month post intervention

  • Change in Health-related Quality of Life

    Baseline, 6 month post intervention, 12 month post intervention

Study Arms (2)

Control

NO INTERVENTION

Experimental: Intervention

EXPERIMENTAL

Participants randomized to the intervention arm will receive the mobile personal health record.

Behavioral: Mobile Personal Health Record App.

Interventions

Mobile Personal Health Record App.BEHAVIORAL
Experimental: Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • one or more of the following conditions: hyperlipidemia, hypertension, diabetes
  • able to give consent
  • patient in the behavioral health home

You may not qualify if:

  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Viewpoint Health & Oakhurst Medical Center

Conyers, Georgia, 30012, United States

Location

Related Publications (1)

  • Druss BG, Li J, Tapscott S, Lally CA. Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes. Psychiatr Serv. 2020 Aug 1;71(8):803-809. doi: 10.1176/appi.ps.201900381. Epub 2020 May 4.

    PMID: 32362226DERIVED

MeSH Terms

Conditions

HypertensionHyperlipidemiasDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Results Point of Contact

Title
Dr. Benjamin Druss
Organization
Emory University
bdruss@emory.edu
404-712-9602

Study Officials

  • Benjamin Druss, MD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 1, 2013

Study Start

November 1, 2014

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

February 17, 2020

Results First Posted

January 30, 2020

Record last verified: 2020-02

Locations

US(1)