Parkinson Disease
Conditions
Keywords
Quality of Health Care, Nursing Care Management, Care Coordination, Randomized Trials
Brief summary
Health care benefits and services are received through the Veterans Health Administration (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a chronic condition that affects motor function as well as cognition, mood, sleep, and autonomic function. There are not enough subspecialists to manage every Veteran with Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates using needs assessments, evidence-based protocols, and VHA and community access coordination mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease care and patient-centered outcomes. If efficacious, this model may be practical to disseminate via an existing VHA national consortium network for Parkinson's disease. Objectives are (1) to implement then analyze via a randomized controlled trial whether a nurse-led, coordinated care management intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence to evidence-based practice guidelines and improve health outcomes in Veterans with Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of implementation of the CHAPS intervention and its costs to determine how the intervention can be made sustainable and disseminated throughout Veterans Affairs Medical Centers if efficacious.
Detailed description
In a 5-year randomized controlled trial, we enrolled 345 Veterans with PD that were then randomized in a 1:1 ratio to receive up to 24 months of a PD care management program, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), or continue with usual care. Eligible participants across 5 sites of the Southwest Parkinson's Disease Research, Education and Clinical Center (SW PADRECC): Greater Los Angeles, Las Vegas, Loma Linda, Long Beach and San Diego VISN 22 (VA Desert Pacific Healthcare Network) facilities were identified through administrative data and vetted by physicians. The multi-faceted nurse-led intervention, CHAPS, incorporated PD quality improvement (QI) tools to enhance proactive Veteran-centered care delivery. PDQI tools included: (1) a structured telephone assessment administered by a nurse care manager (NCM) to proactively identify medical problems and unmet needs; (2) problem-specific evidence-based interventions organized into treatment plans including follow-up/monitoring protocols with VA and community linkages; (3) the Siebens Domain Management ModelTM, a structural approach to improve collection and organization of health information and enrich communication among providers; (4) Siebens Health Care Notebooks prepared with Veteran self-management materials; (5) a Microsoft Access care management database, containing the CHAPS Assessment and algorithms for problem identification based on Veteran data; and (6) decision-support meetings of NCMs with movement disorder specialists. Research interviewers administer a structured telephone survey at baseline, 6, 12, 18, and 24 months. Participants were provided $25 per survey. Medical records were abstracted. Ongoing analyses (1) measure PD quality indicator adherence, health outcomes, and health service utilization; (2) evaluate qualitative and quantitative data to summarize the extent of intervention implementation and barriers and facilitators to potential dissemination; and (3) examine costs of CHAPS care and cost offset between randomization arms to provide new knowledge to aid in future dissemination of the CHAPS Program in a National Rollout according to the VA Quality Enhancement Research Initiative QUERI process.
Interventions
Nurse care managers will use standardized assessment tools and care coordination protocols to address unmet needs of Veterans with PD, and collaborate with these Veterans and their families, providers, and community partners to manage PD care.
To minimize potential bias from participants' awareness of randomization arm assignment, the investigators will provide to all study participants (intervention arm and usual care arm) on enrollment a brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook (page 273). This information includes a definition of PD, its symptoms, and several suggestions for managing PD such as medications and regular exercise.
Sponsors
Study design
Eligibility
Inclusion criteria
* Veteran of the United States of America * Receiving health care at one of five Veterans Health Administration medical centers in the southwest United States: Greater Los Angeles, Loma Linda, Long Beach, or San Diego, California, or Las Vegas, Nevada. * Diagnosis of Parkinson's disease (PD) * At least two ICD-9 diagnostic codes for PD (332.0) in the administrative data from October 1, 2010 - to present date or until recruitment target is met * At least 18 years of age * Must demonstrate capacity to provide consent for study participation.
Exclusion criteria
* Any Veteran who is a study subject in the Deep Brain Stimulation (DBS) VA cooperative study as these subjects are not to enroll in any other study per DBS study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Measures Adhered To in the PD Guidelines | 18 months | Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data. Range and direction of score: 0 (worst) to 1 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities of Daily Living (ADL), (Speech and Swallowing Only) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 0 (best) to 16 (worst) |
| Medical Outcomes Study (MOS) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 5 (best) |
| General Self-Efficacy Scale (GSES) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 10 (worst) to 40 (best) |
| Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 0 (worst) to 100 (best) |
| Health Utilities Index (HUI3) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: -0.36 (worst) to 1 (best) |
| World Health Organization Well-Being Index (WHO-5) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 25 (best) |
| Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. PHQ-2 score ranges from 0 to 4. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Higher scores indicate detection of depressive symptoms |
| Patient Healthcare Questionnaire-9 (PHQ-9) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Range and direction of score: 0 (best) to 27 (worst). Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2 |
| Patient Assessement of Care for Chronic Conditions (PACIC) | 18 months | Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 5 (best) |
Countries
United States
Participant flow
Recruitment details
345 participants enrolled in the study. Subjects were identified by a treating provider while receiving care at 5 Veterans Administration health systems.
Pre-assignment details
13 removed before baseline survey. 4 were ineligible due to not having Parkinson's disease. This left 328 who were randomized
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (Arm 1) A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook. | 166 |
| Intervention (Arm 2) A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook. | 162 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 9 |
| Overall Study | Physician Decision | 7 | 5 |
| Overall Study | Withdrawal by Subject | 7 | 10 |
Baseline characteristics
| Characteristic | Intervention (Arm 2) | Total | Usual Care (Arm 1) |
|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 10.1 | 70.5 years STANDARD_DEVIATION 9.7 | 71.3 years STANDARD_DEVIATION 9.2 |
| Race/Ethnicity, Customized African-American/Black | 9 Participants | 20 Participants | 11 Participants |
| Race/Ethnicity, Customized American-Indian/Alaskan Native | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian-American | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian/White | 125 Participants | 256 Participants | 131 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 21 Participants | 37 Participants | 16 Participants |
| Race/Ethnicity, Customized More than One Race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 2 Participants |
| Sex: Female, Male Male | 155 Participants | 319 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 166 | 9 / 162 |
| other Total, other adverse events | 0 / 166 | 0 / 162 |
| serious Total, serious adverse events | 0 / 166 | 0 / 162 |
Outcome results
Proportion of Measures Adhered To in the PD Guidelines
Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data. Range and direction of score: 0 (worst) to 1 (best)
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Arm 1) | Proportion of Measures Adhered To in the PD Guidelines | 0.77 proportion of quality measures followed | Standard Deviation 0.16 |
| Intervention (Arm 2) | Proportion of Measures Adhered To in the PD Guidelines | 0.58 proportion of quality measures followed | Standard Deviation 0.14 |
Activities of Daily Living (ADL), (Speech and Swallowing Only)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 0 (best) to 16 (worst)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | Baseline | 4.44 units on a scale | Standard Deviation 2.9 |
| Usual Care (Arm 1) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | 6 months | 4.48 units on a scale | Standard Deviation 3 |
| Usual Care (Arm 1) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | 12 months | 4.96 units on a scale | Standard Deviation 3.2 |
| Usual Care (Arm 1) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | 18 months (final) | 5.02 units on a scale | Standard Deviation 3.3 |
| Intervention (Arm 2) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | 18 months (final) | 5.35 units on a scale | Standard Deviation 3.2 |
| Intervention (Arm 2) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | Baseline | 4.68 units on a scale | Standard Deviation 3.1 |
| Intervention (Arm 2) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | 12 months | 5.06 units on a scale | Standard Deviation 3.1 |
| Intervention (Arm 2) | Activities of Daily Living (ADL), (Speech and Swallowing Only) | 6 months | 4.75 units on a scale | Standard Deviation 3.1 |
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 0 (worst) to 100 (best)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | Baseline | 58.72 units on a scale | Standard Error 33.4 |
| Usual Care (Arm 1) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 6 months | 60.18 units on a scale | Standard Error 32.6 |
| Usual Care (Arm 1) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 12 months | 58.25 units on a scale | Standard Error 34.2 |
| Usual Care (Arm 1) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 18 months (final) | 58.55 units on a scale | Standard Error 33.6 |
| Intervention (Arm 2) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 18 months (final) | 53.66 units on a scale | Standard Error 35 |
| Intervention (Arm 2) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | Baseline | 53.42 units on a scale | Standard Error 34.9 |
| Intervention (Arm 2) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 12 months | 54.16 units on a scale | Standard Error 34.5 |
| Intervention (Arm 2) | Consumer Assessment of Healthcare Providers and Systems (CAHPS) | 6 months | 55.34 units on a scale | Standard Error 33.6 |
General Self-Efficacy Scale (GSES)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 10 (worst) to 40 (best)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | General Self-Efficacy Scale (GSES) | Baseline | 33.97 units on a scale | Standard Error 5.1 |
| Usual Care (Arm 1) | General Self-Efficacy Scale (GSES) | 6 months | 34.74 units on a scale | Standard Error 4.9 |
| Usual Care (Arm 1) | General Self-Efficacy Scale (GSES) | 12 months | 35.07 units on a scale | Standard Error 5.1 |
| Usual Care (Arm 1) | General Self-Efficacy Scale (GSES) | 18 months (final) | 35.1 units on a scale | Standard Error 5.1 |
| Intervention (Arm 2) | General Self-Efficacy Scale (GSES) | 18 months (final) | 34.04 units on a scale | Standard Error 5.9 |
| Intervention (Arm 2) | General Self-Efficacy Scale (GSES) | Baseline | 34.17 units on a scale | Standard Error 5.5 |
| Intervention (Arm 2) | General Self-Efficacy Scale (GSES) | 12 months | 34.38 units on a scale | Standard Error 5.7 |
| Intervention (Arm 2) | General Self-Efficacy Scale (GSES) | 6 months | 34.34 units on a scale | Standard Error 5.6 |
Health Utilities Index (HUI3)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: -0.36 (worst) to 1 (best)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | Health Utilities Index (HUI3) | Baseline | 0.48 units on a scale | Standard Deviation 0.3 |
| Usual Care (Arm 1) | Health Utilities Index (HUI3) | 6 months | 0.46 units on a scale | Standard Deviation 0.3 |
| Usual Care (Arm 1) | Health Utilities Index (HUI3) | 12 months | 0.44 units on a scale | Standard Deviation 0.3 |
| Usual Care (Arm 1) | Health Utilities Index (HUI3) | 18 months (final) | 0.40 units on a scale | Standard Deviation 0.3 |
| Intervention (Arm 2) | Health Utilities Index (HUI3) | 18 months (final) | 0.40 units on a scale | Standard Deviation 0.3 |
| Intervention (Arm 2) | Health Utilities Index (HUI3) | Baseline | 0.43 units on a scale | Standard Deviation 0.3 |
| Intervention (Arm 2) | Health Utilities Index (HUI3) | 12 months | 0.42 units on a scale | Standard Deviation 0.3 |
| Intervention (Arm 2) | Health Utilities Index (HUI3) | 6 months | 0.44 units on a scale | Standard Deviation 0.3 |
Medical Outcomes Study (MOS)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 5 (best)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | Medical Outcomes Study (MOS) | Baseline | 3.91 units on a scale | Standard Error 0.9 |
| Usual Care (Arm 1) | Medical Outcomes Study (MOS) | 6 months | 3.93 units on a scale | Standard Error 0.9 |
| Usual Care (Arm 1) | Medical Outcomes Study (MOS) | 12 months | 3.91 units on a scale | Standard Error 0.9 |
| Usual Care (Arm 1) | Medical Outcomes Study (MOS) | 18 months (final) | 3.94 units on a scale | Standard Error 0.9 |
| Intervention (Arm 2) | Medical Outcomes Study (MOS) | 18 months (final) | 4.03 units on a scale | Standard Error 0.7 |
| Intervention (Arm 2) | Medical Outcomes Study (MOS) | Baseline | 4.07 units on a scale | Standard Error 0.8 |
| Intervention (Arm 2) | Medical Outcomes Study (MOS) | 12 months | 4.00 units on a scale | Standard Error 0.8 |
| Intervention (Arm 2) | Medical Outcomes Study (MOS) | 6 months | 3.91 units on a scale | Standard Error 0.8 |
Patient Assessement of Care for Chronic Conditions (PACIC)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 5 (best)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | Patient Assessement of Care for Chronic Conditions (PACIC) | Baselin | 2.34 units on a scale | Standard Error 0.9 |
| Usual Care (Arm 1) | Patient Assessement of Care for Chronic Conditions (PACIC) | 6 months | 2.28 units on a scale | Standard Error 0.8 |
| Usual Care (Arm 1) | Patient Assessement of Care for Chronic Conditions (PACIC) | 12 months | 2.32 units on a scale | Standard Error 0.8 |
| Usual Care (Arm 1) | Patient Assessement of Care for Chronic Conditions (PACIC) | 18 months (final) | 2.37 units on a scale | Standard Error 0.8 |
| Intervention (Arm 2) | Patient Assessement of Care for Chronic Conditions (PACIC) | 18 months (final) | 2.30 units on a scale | Standard Error 0.8 |
| Intervention (Arm 2) | Patient Assessement of Care for Chronic Conditions (PACIC) | Baselin | 2.15 units on a scale | Standard Error 0.8 |
| Intervention (Arm 2) | Patient Assessement of Care for Chronic Conditions (PACIC) | 12 months | 2.28 units on a scale | Standard Error 0.8 |
| Intervention (Arm 2) | Patient Assessement of Care for Chronic Conditions (PACIC) | 6 months | 2.16 units on a scale | Standard Error 0.7 |
Patient Healthcare Questionnaire-9 (PHQ-9)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Range and direction of score: 0 (best) to 27 (worst). Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2
Time frame: 18 months
Population: PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2. At baseline, this was only 13 persons in usual care and 22 persons in the intervention group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | Patient Healthcare Questionnaire-9 (PHQ-9) | Baseline | 12.33 units on a scale | Standard Error 4.4 |
| Usual Care (Arm 1) | Patient Healthcare Questionnaire-9 (PHQ-9) | 6 months | 12.96 units on a scale | Standard Error 4.8 |
| Usual Care (Arm 1) | Patient Healthcare Questionnaire-9 (PHQ-9) | 12 months | 12.44 units on a scale | Standard Error 4.2 |
| Usual Care (Arm 1) | Patient Healthcare Questionnaire-9 (PHQ-9) | 18 months (final) | 12.21 units on a scale | Standard Error 4.8 |
| Intervention (Arm 2) | Patient Healthcare Questionnaire-9 (PHQ-9) | 18 months (final) | 12.46 units on a scale | Standard Error 4.1 |
| Intervention (Arm 2) | Patient Healthcare Questionnaire-9 (PHQ-9) | Baseline | 14.45 units on a scale | Standard Error 3.9 |
| Intervention (Arm 2) | Patient Healthcare Questionnaire-9 (PHQ-9) | 12 months | 12.97 units on a scale | Standard Error 3.6 |
| Intervention (Arm 2) | Patient Healthcare Questionnaire-9 (PHQ-9) | 6 months | 13.22 units on a scale | Standard Error 4.2 |
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. PHQ-2 score ranges from 0 to 4. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Higher scores indicate detection of depressive symptoms
Time frame: 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care (Arm 1) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | Baseline | 13 Participants |
| Usual Care (Arm 1) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 6 months | 15 Participants |
| Usual Care (Arm 1) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 12 months | 11 Participants |
| Usual Care (Arm 1) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 18 months (final) | 23 Participants |
| Intervention (Arm 2) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 18 months (final) | 11 Participants |
| Intervention (Arm 2) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | Baseline | 22 Participants |
| Intervention (Arm 2) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 12 months | 16 Participants |
| Intervention (Arm 2) | Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 | 6 months | 13 Participants |
World Health Organization Well-Being Index (WHO-5)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 25 (best)
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Arm 1) | World Health Organization Well-Being Index (WHO-5) | Baseline | 14.19 units on a scale | Standard Error 5.8 |
| Usual Care (Arm 1) | World Health Organization Well-Being Index (WHO-5) | 6 months | 15.02 units on a scale | Standard Error 5.7 |
| Usual Care (Arm 1) | World Health Organization Well-Being Index (WHO-5) | 12 months | 14.20 units on a scale | Standard Error 6 |
| Usual Care (Arm 1) | World Health Organization Well-Being Index (WHO-5) | 18 months (final) | 14.14 units on a scale | Standard Error 6.3 |
| Intervention (Arm 2) | World Health Organization Well-Being Index (WHO-5) | 18 months (final) | 13.45 units on a scale | Standard Error 6.5 |
| Intervention (Arm 2) | World Health Organization Well-Being Index (WHO-5) | Baseline | 13.14 units on a scale | Standard Error 5.9 |
| Intervention (Arm 2) | World Health Organization Well-Being Index (WHO-5) | 12 months | 13.38 units on a scale | Standard Error 6.5 |
| Intervention (Arm 2) | World Health Organization Well-Being Index (WHO-5) | 6 months | 13.93 units on a scale | Standard Error 5.9 |