Using Telehealth to Improve Psychiatric Symptom Management
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02710344|
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment|
|Mental Disorders||Behavioral: Telehealth Program|
The overarching aim of this study is to evaluate whether telehealth leads to better mental health outcomes and decreased use of acute and crisis-based mental health care services by randomly assigning 300 people with serious mental illness (SMI) and psychiatric instability receiving services at 1 of 2 community mental health centers (CMHCs), each of which offers integrated behavioral and primary health care, to either Health Home Usual Care alone or telehealth plus Health Home Usual Care for 12 months, with assessments at baseline, 3, 6 and 12 months.
This study will evaluate the effectiveness of an automated, algorithmically-driven, customizable telehealth platform that provides education, teaches illness self-management, prompts users to enact coping strategies, and monitors symptoms on a daily basis to remotely detect early warning signs among people with SMI, moving beyond the existing telehealth approaches (mainly educational websites and videoconferencing) for assessing and providing education and therapy to people with SMI.
This study has two specific aims. Aim 1 is to compare the effectiveness of telehealth with Health Home Usual Care by measuring improvements at 6 and 12 months in illness self-management, psychiatric symptoms, and health self-efficacy. Aim 2 is to compare the effectiveness of telehealth with Health Home Usual Care by comparing total cost of emergency room visits and hospital days during the 12 months prior to baseline to total costs of emergency room visits and hospital days during the 12 months after baseline.
This study will evaluate a widely used automated telehealth program that has been modified and upgraded by the research team to incorporate curriculum drawn from illness self-management interventions for SMI developed by the investigators (i.e., Integrated Illness Management and Recovery (I-IMR) and HOPES). Unlike other telehealth devices, it does not require an internet connection and is an efficient and innovative way to provide illness self-monitoring and self-management education. Responses are entered by the user and forwarded to a secure server via cellular signal. The telehealth specialist will access the server daily through a secure website using a username and password.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Automated Telehealth to Improve Psychiatric Self-Management and Community Tenure|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2019|
No Intervention: Usual Care
Usual care at community mental health care provider
Usual care at community mental health care provider PLUS psychiatric telehealth program with remote monitoring.
Behavioral: Telehealth Program
Psychiatric telehealth program, content assigned based on diagnosis, entry to study requires psychiatric instability defined as use of emergency/high cost psychiatric services.
- Total Cost of Emergency Room Visits and Hospital Days [ Time Frame: Change in total cost of emergency room visits and hospital days during the 12 months prior to baseline compared to 12 months after baseline ]Cost of emergency room visits and hospital days
- Psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale [ Time Frame: Change in psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale from baseline to 3, 6, and 12 months ]psychiatric symptom severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710344
|Contact: Meghan M Santos, MSWfirstname.lastname@example.org|
|Contact: Gail Williams, BAemail@example.com|
|United States, New Hampshire|
|Greater Nashua Mental Health Center||Recruiting|
|Nashua, New Hampshire, United States|
|Contact: Susan Flynn, RN 603-889-6147 firstname.lastname@example.org|
|Contact: Meghan M Santos, MSW 603-271-8336 email@example.com|
|United States, Rhode Island|
|The Providence Center||Recruiting|
|Providence, Rhode Island, United States|
|Contact: Holly Fitting HFitting@provctr.org|
|Contact: Mackenzie Wild|