Recruitment

Recruitment Status
Completed
Estimated Enrollment
300

Inclusion Criterias

Age 18 or older and enrolled in treatment for at least 3 months;
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;
...
Age 18 or older and enrolled in treatment for at least 3 months;
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;
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;
Ability to read the telehealth display in English.
An expressed willingness to participate in self-management training or a telehealth program;

Exclusion Criterias

Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
Currently residing in a nursing home or group home;
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.
Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
Currently residing in a nursing home or group home;
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.

Summary

Conditions
  • Bipolar Disorder
  • Depression
  • Schizoaffective Disorder
  • Schizophrenia
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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-man...

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).

Inclusion Criterias

Age 18 or older and enrolled in treatment for at least 3 months;
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;
...
Age 18 or older and enrolled in treatment for at least 3 months;
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;
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;
Ability to read the telehealth display in English.
An expressed willingness to participate in self-management training or a telehealth program;

Exclusion Criterias

Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
Currently residing in a nursing home or group home;
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.
Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
Currently residing in a nursing home or group home;
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.

Locations

Boston, Massachusetts, 02114
Cambridge, Massachusetts, 02141-1001
Boston, Massachusetts, 02114
Cambridge, Massachusetts, 02141-1001

Tracking Information

NCT #
NCT02188732
Collaborators
National Institute of Mental Health (NIMH)
Investigators
Not Provided