Mental DisordersNCT02710344
Using Telehealth to Improve Psychiatric Symptom Management
A study testing Telehealth Program in people with Mental Disorders, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Telehealth Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Chart DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, post-traumatic stress disorder, or major depression and meet criteria for serious mental illness;
- Enrolled in treatment at site for at least 3 months;
- Psychiatric instability as indicated by 2 or more emergency room visits or hospitalizations in the past year, or multiple calls to the psychiatric crisis line within 3 months (10 or more);
- Expressed willingness to participate in a telehealth program;
- Must be able to read English.
Who cannot join
- Currently residing in a nursing home or group home;
- Terminal physical illness which is expected to result in death within one year;
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE) score <24.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greater Nashua Mental Health Center
Nashua, New Hampshire
The Providence Center
Providence, Rhode Island
About this study
Official title: Automated Telehealth to Improve Psychiatric Self-Management and Community Tenure
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.
Read the detailed description
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.
- Conditions
- Mental Disorders
- Being tested
- Telehealth Program
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth ProgramBehavioural
Psychiatric telehealth program, content assigned based on diagnosis, entry to study requires psychiatric instability defined as use of emergency/high cost psychiatric services.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care at community mental health care provider |
| Telehealth | Experimental | Usual care at community mental health care provider PLUS psychiatric telehealth program with remote monitoring. Receives: Behavioral: Telehealth Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cost of Emergency Room Visits and Hospital Days
Cost of emergency room visits and hospital days
Measured: Change in total cost of emergency room visits and hospital days during the 12 months prior to baseline compared to 12 months after baseline
Secondary outcomes (1)
Psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale
psychiatric symptom severity
Measured: Change in psychiatric symptom severity as assessed using the Brief Psychiatric Rating Scale from baseline to 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah Pratt, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710344
- Sponsor's protocol ID
- 28105
- Other IDs
- R01MH107625
- Status last verified
- Nov 2020
- First submitted
- 10 Mar 2016
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Telehealth to Improve Psychiatric Self-Management and Community Tenure
- ClinicalTrials.gov ID
- NCT02710344
- Acronym / sponsor ID
- 28105
- Conditions
- Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care at community mental health care provider |
| Telehealth | Experimental | Behavioral: Telehealth ProgramUsual care at community mental health care provider PLUS psychiatric telehealth program with remote monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older;
- Chart DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, post-traumatic stress disorder, or major depression and meet criteria for serious mental illness;
- Enrolled in treatment at site for at least 3 months;
- Psychiatric instability as indicated by 2 or more emergency room visits or hospitalizations in the past year, or multiple calls to the psychiatric crisis line within 3 months (10 or more);
- Expressed willingness to participate in a telehealth program;
Key exclusion criteria (3 listed)
- Currently residing in a nursing home or group home;
- Terminal physical illness which is expected to result in death within one year;
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE) score <24.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth ProgramPsychiatric telehealth program, content assigned based on diagnosis, entry to study requires psychiatric instability defined as use of emergency/high cost psychiatric services. | Behavioural | Telehealth |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Program in people with Mental Disorders, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.