- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01890226
A Mobile Personal Health Record for Behavioral Health Homes (mPHR)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Georgia
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Conyers, Georgia, Forente stater, 30012
- Viewpoint Health & Oakhurst Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Styre
|
|
Eksperimentell: Experimental: Intervention
Participants randomized to the intervention arm will receive the mobile personal health record.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Composite Quality Score
Tidsramme: Baseline, 12 month post intervention
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Patient Assessment of Chronic Illness Care
Tidsramme: Baseline, 6 month post intervention, 12 month post intervention
|
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
|
Change in Patient Activation Measure
Tidsramme: Baseline, 6 month post intervention, 12 month post intervention
|
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
|
Change in Health-related Quality of Life
Tidsramme: Baseline, 6 month post intervention, 12 month post intervention
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Benjamin Druss, MD, MPH, Emory University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00067447
- 1R01MH100467-01 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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