SchizophreniaNCT02188732
Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
A study testing CBHH+AT, CBHH+SMT and CBHH in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- CBHH+AT, CBHH+SMT and CBHH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 31 Jul 2021
- 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
- Age 18 or older and enrolled in treatment for at least 3 months;
- SMI as defined by (i) primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder; (ii) moderate impairment across multiple areas of psychosocial functioning, including social relationships, self-care, community/work activity, treatment self-management, and community living skills; (iii) GAF (Global Assessment of Functioning) score less than 61. The broad range of SMI are included primarily because findings will be more generalizable to routine mental health settings, but also because we included this group in our pilot studies;
- Diagnosis of one of the following medical illnesses or health conditions: diabetes, heart disease, chronic obstructive pulmonary disease, chronic pain, hyperlipidemia, hypertension, obesity, tobacco dependence;
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian;
- An expressed willingness to participate in self-management training or a telehealth program;
- Ability to read the telehealth display in English.
Who cannot join
- Currently residing in a nursing home or group home;
- Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE)74 score <24.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bay Cove Human Services
Boston, Massachusetts, 02114
Vinfen
Cambridge, Massachusetts, 02141-1001
About this study
This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses:
Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management and greater mental health self-management.
Read more
Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.
Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use and less acute service use costs.
Read the detailed description
Efforts to reduce early mortality in persons with serious mental illness (SMI) have largely focused on providing integrated primary care in a "health home". Yet medical care alone accounts for a disproportionately small contribution to reductions in early morality in comparison to improving self-management and health behaviors. Illness self-management training (SMT) in the general population has been shown to improve health outcomes and lower costs associated with chronic health conditions by teaching and coaching individuals on monitoring symptoms, self-administering treatments, and improving health behaviors. More recently, the use of technologies such as Automated Telehealth (AT) has been shown to improve outcomes and potentially prevent expensive emergency room and acute hospitalizations in the general population by daily prompting of self-management and remote monitoring by a nurse who can pre-emptively intervene, guided by disease management algorithms. To the investigators knowledge, neither of these approaches has been empirically evaluated as an integrated component in a behavioral health home for persons with SMI. The investigators will conduct a randomized clinical trial (RCT) of 300 persons with SMI and medical comorbidity to evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses:
Primary H1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management (measured by the Self Rated Abilities for Health Practices Scale) and (Exploratory E1) greater mental health self-management (measured by the Illness Management and Recovery Scale) at 4, 8, 12, and 24-months. Primary H2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality (as measured by the Avoidable Mortality Risk Index) and (Exploratory E2) in psychiatric symptoms (BPRS) at 4, 8, 12, and 24 months. Primary H3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use (emergency room visits and hospitalizations) and (Exploratory E3) less acute service use costs at 4, 8, 12, and 24-months.
In order to differentiate CBHH+SMT and CBHH+AT if both are found to be effective, the investigators will evaluate the persistence of primary outcomes from intervention endpoint (at 12 months) to the final follow-up (at 24 months) and will calculate the additional incremental costs of implementing and providing SMT and AT. The investigators will also explore differences in subjective health (SF-12) and in individual cardiovascular risk factors (e.g., BMI, tobacco use, blood pressure, glucose, lipids), comparing CBHH+SMT, CBHH+AT, and CBHH alone. Finally, the investigators will explore hypothesized mechanisms of action (potential mediators) for the Aim 2 primary outcome of reduced risk of early mortality (i.e., improvement in health self-management) and for the Aim 3 primary outcome of less acute service use (i.e., medication adherence and number of nurse preemptive interventions).
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression
- Being tested
- CBHH+AT, CBHH+SMT, CBHH
- Keywords
- Community Mental Health, Serious Mental Illness, Medical Comorbidity, Self-Management, Automated Telehealth, Early Mortality
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBHH+ATBehavioural
Also called Person and Family-Centered Health Home, Automated Telehealth, Health Buddy
Community Based Health Home + Automated Telehealth (CBHH+AT):
Community-Based Health Home (CBHH) PLUS Automated Telehealth: a wireless telehealth device programmed with psychiatric content corresponding to the primary psychiatric diagnosis, and medical content tailored to the primary medical diagnosis. Daily interactive sessions last 5-10 min. Branching logic tailors questions or feedback to the user's responses (e.g., if a participant endorses medication nonadherence, a question appears asking why medications were not taken). The device automatically provides specific instructions to participants demonstrating signs of high risk.
CBHH+SMTBehavioural
Also called Illness Self-management, Self-mangement support, Integrated Illness Self-management and Recovery
Illness Management and Recovery (IMR) for psychiatric illness combines (1) psychoeducation, which improves knowledge about mental illness management, (2) behavioral tailoring, which improves medication adherence, (3) relapse prevention training, which decreases relapses and rehospitalizations, and (4) coping skills training, which reduces distress related to symptoms. Illness Management and Recovery (I-IMR) by adding chronic medical illness self-management to psychiatric illness self-management. For each psychiatric self-management skill module, there is a corresponding medical illness self-management training component using established methods in self-management of common chronic health conditions (e.g., diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, etc.).
CBHHBehavioural
Also called Patient centered health home, Behavioral health home, Chronic disease management
Community-based Health Home (CBHH): Each team has a staff-to-participant ratio of approximately 1:12, with each team serving approximately 120 participants with SMI using person-centered planning and recovery-oriented, flexible service models. Each team provides mobile outreach and includes a team leader; a peer counselor; a psychiatric nurse coordinator; a clinical care coordinator; specialists in substance abuse (dual diagnosis), community integration, rehabilitation, employment, and housing; and a medical nurse practitioner (MNP) and a health outreach worker (HOW).
| Study group | Role | What they receive |
|---|---|---|
| CBHH+AT | Experimental | Community Based Health Home + Automated Telehealth (CBHH+AT):
Community-Based Health Home (CBHH) PLUS Automated Telehealth: a wireless telehealth device programmed with psychiatric content corresponding to the primary psychiatric diagnosis, and medical content tailored to the primary medical diagnosis. Daily interactive sessions last 5-10 min. Branching logic tailors questions or feedback to the user's responses (e.g., if a participant endorses medication nonadherence, a question appears asking why medications were not taken). The device automatically provides specific instructions to participants demonstrating signs of high risk. Receives: Behavioral: CBHH+AT; Behavioral: CBHH |
| CBHH+SMT | Active comparator | CBHH+SMT Community-Based Health Home (CBHH) PLUS Self-Management Training (SMT) of I-IMR
I-IMR integrates psychiatric illness self-management with strategies for medical illness self-management . The psychiatric component includes psychoeducation about illness and treatment, cognitive behavioral approaches to increase medication adherence, training and relapse prevention, teaching coping skills to manage persistent symptoms, and social skills training. The medical illness component consists of an individually tailored curriculum focused on managing physical illnesses using parallel skills and strategies taught for psychiatric illness self-management, as well as a nurse health care manager to facilitate coordination of necessary preventive and ongoing health care. The I-IMR curriculum consists of 10 modules delivered by an I-IMR specialist through eight months of weekly sessions customized to the specific needs and disorders of each client. Receives: Behavioral: CBHH+SMT; Behavioral: CBHH |
| CBHH | Active comparator | Community-based Health Home (CBHH): Each team has a staff-to-participant ratio of approximately 1:12, with each team serving approximately 120 participants with SMI using person-centered planning and recovery-oriented, flexible service models. Each team provides mobile outreach and includes a team leader; a peer counselor; a psychiatric nurse coordinator; a clinical care coordinator; specialists in substance abuse (dual diagnosis), community integration, rehabilitation, employment, and housing; and a medical nurse practitioner (MNP) and a health outreach worker (HOW) Receives: Behavioral: CBHH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Self-management
Self Rated Abilities for Health Practices Scale
Measured: Change from baseline at 4,8,12, and 24 months
Change in risk of early mortality
Avoidable Mortality Risk Index
Measured: Change from baseline at 4,8,12, and 24 months
Change in acute service use
emergency room visits and hospitalizations
Measured: Change from baseline at 4,8,12, and 24 months
Secondary outcomes (3)
Change in mental health self-management
Illness Management and Recovery Scale
Measured: Change from baseline at 4,8,12, and 24 months
Change in psychiatric symptom severity
Brief Psychiatric Rating Scale
Measured: Change from baseline at 4,8,12, and 24 months
Change in acute care costs
emergency room and hospitalization costs
Measured: Change from baseline at 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJan 2015
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 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, Stephen J. Bartels, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188732
- Sponsor's protocol ID
- 11522753
- Status last verified
- Aug 2021
- First submitted
- 9 Jul 2014
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bartels SJ, Pratt SI, Mueser KT, Naslund JA, Wolfe RS, Santos M, Xie H, Riera EG. Integrated IMR for psychiatric and general medical illness for adults aged 50 or older with serious mental illness. Psychiatr Serv. 2014 Mar 1;65(3):330-7. doi: 10.1176/appi.ps.201300023.
PubMed 24292559Pratt SI, Bartels SJ, Mueser KT, Naslund JA, Wolfe R, Pixley HS, Josephson L. Feasibility and effectiveness of an automated telehealth intervention to improve illness self-management in people with serious psychiatric and medical disorders. Psychiatr Rehabil J. 2013 Dec;36(4):297-305. doi: 10.1037/prj0000022.
PubMed 24320837
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
- ClinicalTrials.gov ID
- NCT02188732
- Acronym / sponsor ID
- 11522753
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression
- Keywords
- Community Mental Health, Serious Mental Illness, Medical Comorbidity, Self-Management, Automated Telehealth, Early Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 14 Jul 2014 (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.
This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses:
Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management and greater mental health self-management.
Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.
Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use and less acute service use costs.
Detailed description
Efforts to reduce early mortality in persons with serious mental illness (SMI) have largely focused on providing integrated primary care in a "health home". Yet medical care alone accounts for a disproportionately small contribution to reductions in early morality in comparison to improving self-management and health behaviors. Illness self-management training (SMT) in the general population has been shown to improve health outcomes and lower costs associated with chronic health conditions by teaching and coaching individuals on monitoring symptoms, self-administering treatments, and improving health behaviors. More recently, the use of technologies such as Automated Telehealth (AT) has been shown to improve outcomes and potentially prevent expensive emergency room and acute hospitalizations in the general population by daily prompting of self-management and remote monitoring by a nurse who can pre-emptively intervene, guided by disease management algorithms. To the investigators knowledge, neither of these approaches has been empirically evaluated as an integrated component in a behavioral health home for persons with SMI. The investigators will conduct a randomized clinical trial (RCT) of 300 persons with SMI and medical comorbidity to evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses:
Primary H1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management (measured by the Self Rated Abilities for Health Practices Scale) and (Exploratory E1) greater mental health self-management (measured by the Illness Management and Recovery Scale) at 4, 8, 12, and 24-months. Primary H2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality (as measured by the Avoidable Mortality Risk Index) and (Exploratory E2) in psychiatric symptoms (BPRS) at 4, 8, 12, and 24 months. Primary H3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use (emergency room visits and hospitalizations) and (Exploratory E3) less acute service use costs at 4, 8, 12, and 24-months.
In order to differentiate CBHH+SMT and CBHH+AT if both are found to be effective, the investigators will evaluate the persistence of primary outcomes from intervention endpoint (at 12 months) to the final follow-up (at 24 months) and will calculate the additional incremental costs of implementing and providing SMT and AT. The investigators will also explore differences in subjective health (SF-12) and in individual cardiovascular risk factors (e.g., BMI, tobacco use, blood pressure, glucose, lipids), comparing CBHH+SMT, CBHH+AT, and CBHH alone. Finally, the investigators will explore hypothesized mechanisms of action (potential mediators) for the Aim 2 primary outcome of reduced risk of early mortality (i.e., improvement in health self-management) and for the Aim 3 primary outcome of less acute service use (i.e., medication adherence and number of nurse preemptive interventions).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBHH+AT | Experimental | Behavioral: CBHH+AT, Behavioral: CBHHCommunity Based Health Home + Automated Telehealth (CBHH+AT): Community-Based Health Home (CBHH) PLUS Automated Telehealth: a wireless telehealth device programmed with psychiatric content corresponding to the primary psychiatric diagnosis, and medical content tailored to the primary medical diagnosis. Daily interactive sessions last 5-10 min. Branching logic tailors questions or feedback to the user's responses (e.g., if a participant endorses medication nonadherence, a question appears asking why medications were not taken). The device automatically provides specific instructions to participants demonstrating signs of high risk. |
| CBHH+SMT | Active comparator | Behavioral: CBHH+SMT, Behavioral: CBHHCBHH+SMT Community-Based Health Home (CBHH) PLUS Self-Management Training (SMT) of I-IMR I-IMR integrates psychiatric illness self-management with strategies for medical illness self-management . The psychiatric component includes psychoeducation about illness and treatment, cognitive behavioral approaches to increase medication adherence, training and relapse prevention, teaching coping skills to manage persistent symptoms, and social skills training. The medical illness component consists of an individually tailored curriculum focused on managing physical illnesses using parallel skills and strategies taught for psychiatric illness self-management, as well as a nurse health care manager to facilitate coordination of necessary preventive and ongoing health care. The I-IMR curriculum consists of 10 modules delivered by an I-IMR specialist through eight months of weekly sessions customized to the specific needs and disorders of each client. |
| CBHH | Active comparator | Behavioral: CBHHCommunity-based Health Home (CBHH): Each team has a staff-to-participant ratio of approximately 1:12, with each team serving approximately 120 participants with SMI using person-centered planning and recovery-oriented, flexible service models. Each team provides mobile outreach and includes a team leader; a peer counselor; a psychiatric nurse coordinator; a clinical care coordinator; specialists in substance abuse (dual diagnosis), community integration, rehabilitation, employment, and housing; and a medical nurse practitioner (MNP) and a health outreach worker (HOW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older and enrolled in treatment for at least 3 months;
- SMI as defined by (i) primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder; (ii) moderate impairment across multiple areas of psychosocial functioning, including social relationships, self-care, community/work activity, treatment self-management, and community living skills; (iii) GAF (Global Assessment of Functioning) score less than 61. The broad range of SMI are included primarily because findings will be more generalizable to routine mental health settings, but also because we included this group in our pilot studies;
- Diagnosis of one of the following medical illnesses or health conditions: diabetes, heart disease, chronic obstructive pulmonary disease, chronic pain, hyperlipidemia, hypertension, obesity, tobacco dependence;
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian;
- An expressed willingness to participate in self-management training or a telehealth program;
Key exclusion criteria (3 listed)
- Currently residing in a nursing home or group home;
- Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE)74 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 |
|---|---|---|
| CBHH+ATAlso: Person and Family-Centered Health Home, Automated Telehealth, Health BuddyCommunity Based Health Home + Automated Telehealth (CBHH+AT): Community-Based Health Home (CBHH) PLUS Automated Telehealth: a wireless telehealth device programmed with psychiatric content corresponding to the primary psychiatric diagnosis, and medical content tailored to the primary medical diagnosis. Daily interactive sessions last 5-10 min. Branching logic tailors questions or feedback to the user's responses (e.g., if a participant endorses medication nonadherence, a question appears asking why medications were not taken). The device automatically provides specific instructions to participants demonstrating signs of high risk. | Behavioural | CBHH+AT |
| CBHH+SMTAlso: Illness Self-management, Self-mangement support, Integrated Illness Self-management and RecoveryIllness Management and Recovery (IMR) for psychiatric illness combines (1) psychoeducation, which improves knowledge about mental illness management, (2) behavioral tailoring, which improves medication adherence, (3) relapse prevention training, which decreases relapses and rehospitalizations, and (4) coping skills training, which reduces distress related to symptoms. Illness Management and Recovery (I-IMR) by adding chronic medical illness self-management to psychiatric illness self-management. For each psychiatric self-management skill module, there is a corresponding medical illness self-management training component using established methods in self-management of common chronic health conditions (e.g., diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, etc.). | Behavioural | CBHH+SMT |
| CBHHAlso: Patient centered health home, Behavioral health home, Chronic disease managementCommunity-based Health Home (CBHH): Each team has a staff-to-participant ratio of approximately 1:12, with each team serving approximately 120 participants with SMI using person-centered planning and recovery-oriented, flexible service models. Each team provides mobile outreach and includes a team leader; a peer counselor; a psychiatric nurse coordinator; a clinical care coordinator; specialists in substance abuse (dual diagnosis), community integration, rehabilitation, employment, and housing; and a medical nurse practitioner (MNP) and a health outreach worker (HOW). | Behavioural | CBHH, CBHH+AT, CBHH+SMT |
Primary outcome
Change in Health Self-management
Time frame: Change from baseline at 4,8,12, and 24 months
Self Rated Abilities for Health Practices Scale
Change in risk of early mortality
Time frame: Change from baseline at 4,8,12, and 24 months
Avoidable Mortality Risk Index
Change in acute service use
Time frame: Change from baseline at 4,8,12, and 24 months
emergency room visits and hospitalizations
3 secondary outcomes
Change in mental health self-management
Time frame: Change from baseline at 4,8,12, and 24 months
Change in psychiatric symptom severity
Time frame: Change from baseline at 4,8,12, and 24 months
Change in acute care costs
Time frame: Change from baseline at 12 and 24 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 27 Aug 2021.
- Background: PubMed 24292559Bartels SJ, Pratt SI, Mueser KT, Naslund JA, Wolfe RS, Santos M, Xie H, Riera EG. Integrated IMR for psychiatric and general medical illness for adults aged 50 or older with serious mental illness. Psychiatr Serv. 2014 Mar 1;65(3):330-7. doi: 10.1176/appi.ps.201300023.
- Background: PubMed 24320837Pratt SI, Bartels SJ, Mueser KT, Naslund JA, Wolfe R, Pixley HS, Josephson L. Feasibility and effectiveness of an automated telehealth intervention to improve illness self-management in people with serious psychiatric and medical disorders. Psychiatr Rehabil J. 2013 Dec;36(4):297-305. doi: 10.1037/prj0000022.
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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 CBHH+AT, CBHH+SMT and CBHH in people with Schizophrenia and Schizoaffective Disorder, 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 27 Aug 2021. 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?
Change in Health Self-management (time frame: Change from baseline at 4,8,12, and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188732, which also lists 2 linked publications.
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 27 Aug 2021.