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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.
Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care.
Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes?
Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calmer Life | Experimental | Cognitive behavior treatment for anxiety |
|
| Enhanced Community Care | Active Comparator | Enhanced information and referral services for mental health and basic needs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior treatment | Behavioral | Anxiety management skills with the option to included religious/spiritual beliefs and practices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. | Baseline, 6 months |
| Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. | Baseline, 9 months |
| Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. | Baseline, 6 months |
| Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. | Baseline, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. | Baseline, 6 months |
| Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda A Stanley, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt) | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30224269 | Derived | Stanley MA, Wilson NL, Shrestha S, Amspoker AB, Wagener P, Bavineau J, Turner M, Fletcher TL, Freshour J, Kraus-Schuman C, Kunik ME. Community-Based Outreach and Treatment for Underserved Older Adults With Clinically Significant Worry: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2018 Nov;26(11):1147-1162. doi: 10.1016/j.jagp.2018.07.011. Epub 2018 Aug 7. | |
| 28961662 |
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Prior to random assignment, participants were screened at three separate times. During this process, 84 participants were ineligible due to presence of exclusionary criteria, 24 were lost to follow-up and 5 withdrew from the study.
Recruitment occurred from February 2015 through October 2016 in community settings where older adults gather and/or receive services such as social service agencies, churches, senior housing and community centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calmer Life | Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices |
| FG001 | Enhanced Community Care | Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Calmer Life | Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices |
| BG001 | Enhanced Community Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
2.5 years
No adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calmer Life | Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda A. Stanley, PhD | Baylor College of Medicine | 713-794-8841 | mstanley@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2018 | Feb 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Information and referral | Behavioral | Resource counseling and follow-up for mental health and basic needs |
|
Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. |
| Baseline, 9 months |
| Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. | Baseline, 6 months |
| Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. | Baseline, 9 months |
| Geriatric Depression Scale Short Form (GDS) at 6 Months | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. | Baseline, 6 months |
| Geriatric Depression Scale Short Form (GDS) at 9 Months | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. | Baseline, 9 months |
| Insomnia Severity Index (ISI) at 6 Months | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. | Baseline, 6 months |
| Insomnia Severity Index (ISI) at 9 Months | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. | Baseline, 9 months |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. | Baseline, 6 months |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. | Baseline, 9 months |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. | Baseline, 6 months |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. | Baseline, 9 months |
| Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. | Baseline, 6 months |
| Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. | Baseline, 9 months |
| Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. | Baseline, 6 months |
| Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. | Baseline, 9 months |
| PTSD Checklist-5 (PCL-5) Total at 6 Months | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. | Baseline, 6 months |
| PTSD Checklist-5 (PCL-5) Total at 9 Months | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. | Baseline, 9 months |
| Health Service Use at 6 Months | Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. | Baseline, 6 months |
| Health Service Use at 9 Months | Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. | Baseline, 9 months |
| Hospital Admissions at 6 Months | Number of participants who were admitted to a hospital in the past 3 months. | Baseline, 6 months |
| Hospital Admissions at 9 Months | Number of participants who were admitted to a hospital in the past 3 months. | Baseline, 9 months |
| Social Service or Resource Use at 6 Months | Number of participants who received social services or resources over the past 3 months | Baseline, 6 months |
| Social Service or Resource Use at 9 Months | Number of participants who received social services or resources over the past 3 months | Baseline, 9 months |
| Psychological Service Use at 6 Months | Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months | Baseline, 6 months |
| Psychological Service Use at 9 Months | Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months | Baseline, 9 months |
| Steiner AJ, Boulos N, Wright SM, Mirocha J, Smith K, Lopez E, Gohar SH, Ishak WW. Major Depressive Disorder in Patients With Doctoral Degrees: Patient-reported Depressive Symptom Severity, Functioning, and Quality of Life Before and After Initial Treatment in the STAR*D Study. J Psychiatr Pract. 2017 Sep;23(5):328-341. doi: 10.1097/PRA.0000000000000251. |
| 28492456 | Derived | Shrestha S, Wilson N, Kunik ME, Wagener P, Amspoker AB, Barrera T, Freshour J, Kraus-Schuman C, Bavineau J, Turner M, Stanley MA. Calmer Life: A Hybrid Effectiveness-implementation Trial for Late-life Anxiety Conducted in Low-income, Mental Health-Underserved Communities. J Psychiatr Pract. 2017 May;23(3):180-190. doi: 10.1097/PRA.0000000000000234. |
Enhanced information and referral services for mental health and basic needs
Information and referral: Resource counseling and follow-up for mental health and basic needs
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Marital Status | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Psychotropic Medication Use | Count of Participants | Participants |
|
| Medication Use, Total | Mean | Standard Deviation | number of medications |
|
| Diagnoses | Count of Participants | Participants |
|
| Service Use | Count of Participants | Participants |
|
| Expectancy Rating Scale (ERS) Cred | Measure of participant perception of the credibility of the intervention. Scores range from 3 to 30. Higher Scores indicate greater credibility. | The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure. | Mean | Standard Deviation | units on a scale |
|
| Expectancy Rating Scale (ERS) Exp | Measure of participant expectancy of improvement from intervention. Single item scores range from 0 to 10. Higher scores indicate greater expectations. | The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure. | Mean | Standard Deviation | units on a scale |
|
| Penn State Worry Questionnaire-A (PSWQ-A) | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. | Mean | Standard Deviation | units on a scale |
|
| Generalized Anxiety Disorder-7 (GAD-7) | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Geriatric Anxiety Inventory-SF (GAI-SF) | Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. | Mean | Standard Deviation | units on a scale |
|
| Geriatric Depression Scale Short Form (GDS) | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. | Mean | Standard Deviation | units on a scale |
|
| Insomnia Severity Index (ISI) | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. | Mean | Standard Deviation | units on a scale |
|
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. | Mean | Standard Deviation | units on a scale |
|
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist-5 (PCL-5) Total | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire depression scale (PHQ 8) | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. | Mean | Standard Deviation | units on a scale |
|
| Brief RCOPE Positive Subscale | The Brief RCOPE is a 14 item measure of religious coping. The positive religious coping subscale includes 7 items rated from 0 (not at all) to 3 (great deal). Subscale scores range from 0-21. Higher scores indicate greater positive religious coping. | The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample | Mean | Standard Deviation | units on a scale |
|
| Brief RCOPE Negative subscale | The Brief RCOPE is a 14 item measure of religious coping. The negative religious coping subscale includes 7 items rated from 0 (not at all) to 3 (great deal). Subscale scores range from 0-21. Higher scores indicate greater negative religious coping. | The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample | Mean | Standard Deviation | units on a scale |
|
| Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. | Mean | Standard Deviation | units on a scale |
|
| Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. | Mean | Standard Deviation | units on a scale |
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| Primary | Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Primary | Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Primary | Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months | Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Geriatric Depression Scale Short Form (GDS) at 6 Months | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Geriatric Depression Scale Short Form (GDS) at 9 Months | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Insomnia Severity Index (ISI) at 6 Months | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Insomnia Severity Index (ISI) at 9 Months | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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| Secondary | PTSD Checklist-5 (PCL-5) Total at 6 Months | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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| Secondary | PTSD Checklist-5 (PCL-5) Total at 9 Months | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. | 134 participants who completed baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 9 months |
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|
|
| Secondary | Health Service Use at 6 Months | Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
|
| Secondary | Health Service Use at 9 Months | Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 9 months |
|
|
|
|
| Secondary | Hospital Admissions at 6 Months | Number of participants who were admitted to a hospital in the past 3 months. | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
|
| Secondary | Hospital Admissions at 9 Months | Number of participants who were admitted to a hospital in the past 3 months. | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 9 months |
|
|
|
|
| Secondary | Social Service or Resource Use at 6 Months | Number of participants who received social services or resources over the past 3 months | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
|
| Secondary | Social Service or Resource Use at 9 Months | Number of participants who received social services or resources over the past 3 months | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 9 months |
|
|
|
|
| Secondary | Psychological Service Use at 6 Months | Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
|
| Secondary | Psychological Service Use at 9 Months | Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months | 134 participants who completed baseline assessment. | Posted | Count of Participants | Participants | Baseline, 9 months |
|
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Enhanced Community Care | Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs | 0 | 64 | 0 | 64 | 0 | 64 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Separated |
|
| Divorced |
|
| Widowed |
|
| $20,000 - $30,000 |
|
| $30,000 - $40,000 |
|
| $40,000 - $50,000 |
|
| $50,000 - $60,000 |
|
| ≥$60,000 |
|
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |