An Electronic Personal Health Record for Mental Health Co... | NCT01724125

Studies
An Electronic Personal Health Record for Mental Health Consumers

NCT01724125

Sponsor

Emory University

Status

Completed

Last Update Posted

Aug 5, 2016Estimated

Enrollment

170Actual

Phase

Phase 3

Conditions

Chronic Comorbid Conditions

Interventions

personal electronic medical record

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R18HS017829	U.S. AHRQ Grant/Contract		View source

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Apr 25, 2012

First Submission Date that Met QC Criteria

Nov 6, 2012

First Posted Date

Nov 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2016

Last Update Posted Date

Aug 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Druss, Professor, Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH
Agency for Healthcare Research and Quality (AHRQ)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by shifting the ownership and locus of health records from being scattered across multiple providers to an approach that is longitudinal and patient-centered. Given the complex health needs and the fragmentation of care for persons with serious mental illnesses, these individuals could derive particular benefit from a PHR. However, there are currently no established PHRs developed for use in this population.

In order to fill this gap, the investigators propose to develop, test, and disseminate a Personal Health Record for persons with serious mental illnesses and one or more comorbid medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health record which was developed in partnership with medical consumers and is in wide use in a number of communities in the United States and abroad.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case	Experimental	Assigned a Personal Electronic Health Record	Other: personal electronic medical record
Control: Usual Care	Active Comparator	Assigned to control arm, continued to receive care as usual in community. Was issued information on community health resources, but did not use research study personal health record.	Other: personal electronic medical record

Interventions

Name	Type	Description	Arm Group Labels	Other Names
personal electronic medical record	Other		Case Control: Usual Care

Measure	Description	Time Frame
Quality of Care		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently in treatment at the CMHC.
Serious Mental Illness: based on or chart review;
One or more Chronic Medical Condition as ascertained via administrative records.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Druss, MD MPH	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grady Health Systems		Atlanta	Georgia	30303	United States