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Randomized Trial to Test the Coordinated Care for Health Promotion and Activities in Parkinson's Disease Intervention in the VA

Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01532986
Acronym
CHAPS
Enrollment
345
Registered
2012-02-15
Start date
2012-07-09
Completion date
2017-04-30
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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

OTHERCoordinated care management for Parkinson's disease

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

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Proportion of Measures Adhered To in the PD Guidelines18 monthsAdherence 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

MeasureTime frameDescription
Activities of Daily Living (ADL), (Speech and Swallowing Only)18 monthsData 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 monthsData 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 monthsData 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 monthsData 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 monthsData 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 monthsData 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 ≥ 318 monthsData 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 monthsData 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 monthsData 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

ArmCount
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
Total328

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath99
Overall StudyPhysician Decision75
Overall StudyWithdrawal by Subject710

Baseline characteristics

CharacteristicIntervention (Arm 2)TotalUsual Care (Arm 1)
Age, Continuous69.6 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 Participants20 Participants11 Participants
Race/Ethnicity, Customized
American-Indian/Alaskan Native
2 Participants5 Participants3 Participants
Race/Ethnicity, Customized
Asian-American
3 Participants3 Participants0 Participants
Race/Ethnicity, Customized
Caucasian/White
125 Participants256 Participants131 Participants
Race/Ethnicity, Customized
Hispanic/Latino
21 Participants37 Participants16 Participants
Race/Ethnicity, Customized
More than One Race
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
0 Participants3 Participants3 Participants
Race/Ethnicity, Customized
Other
2 Participants3 Participants1 Participants
Sex: Female, Male
Female
7 Participants9 Participants2 Participants
Sex: Female, Male
Male
155 Participants319 Participants164 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
9 / 1669 / 162
other
Total, other adverse events
0 / 1660 / 162
serious
Total, serious adverse events
0 / 1660 / 162

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Usual Care (Arm 1)Proportion of Measures Adhered To in the PD Guidelines0.77 proportion of quality measures followedStandard Deviation 0.16
Intervention (Arm 2)Proportion of Measures Adhered To in the PD Guidelines0.58 proportion of quality measures followedStandard Deviation 0.14
p-value: >0.0595% CI: [0.157, 0.222]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)Activities of Daily Living (ADL), (Speech and Swallowing Only)Baseline4.44 units on a scaleStandard Deviation 2.9
Usual Care (Arm 1)Activities of Daily Living (ADL), (Speech and Swallowing Only)6 months4.48 units on a scaleStandard Deviation 3
Usual Care (Arm 1)Activities of Daily Living (ADL), (Speech and Swallowing Only)12 months4.96 units on a scaleStandard Deviation 3.2
Usual Care (Arm 1)Activities of Daily Living (ADL), (Speech and Swallowing Only)18 months (final)5.02 units on a scaleStandard Deviation 3.3
Intervention (Arm 2)Activities of Daily Living (ADL), (Speech and Swallowing Only)18 months (final)5.35 units on a scaleStandard Deviation 3.2
Intervention (Arm 2)Activities of Daily Living (ADL), (Speech and Swallowing Only)Baseline4.68 units on a scaleStandard Deviation 3.1
Intervention (Arm 2)Activities of Daily Living (ADL), (Speech and Swallowing Only)12 months5.06 units on a scaleStandard Deviation 3.1
Intervention (Arm 2)Activities of Daily Living (ADL), (Speech and Swallowing Only)6 months4.75 units on a scaleStandard Deviation 3.1
p-value: >0.0595% CI: [-0.52, 0.57]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)Consumer Assessment of Healthcare Providers and Systems (CAHPS)Baseline58.72 units on a scaleStandard Error 33.4
Usual Care (Arm 1)Consumer Assessment of Healthcare Providers and Systems (CAHPS)6 months60.18 units on a scaleStandard Error 32.6
Usual Care (Arm 1)Consumer Assessment of Healthcare Providers and Systems (CAHPS)12 months58.25 units on a scaleStandard Error 34.2
Usual Care (Arm 1)Consumer Assessment of Healthcare Providers and Systems (CAHPS)18 months (final)58.55 units on a scaleStandard Error 33.6
Intervention (Arm 2)Consumer Assessment of Healthcare Providers and Systems (CAHPS)18 months (final)53.66 units on a scaleStandard Error 35
Intervention (Arm 2)Consumer Assessment of Healthcare Providers and Systems (CAHPS)Baseline53.42 units on a scaleStandard Error 34.9
Intervention (Arm 2)Consumer Assessment of Healthcare Providers and Systems (CAHPS)12 months54.16 units on a scaleStandard Error 34.5
Intervention (Arm 2)Consumer Assessment of Healthcare Providers and Systems (CAHPS)6 months55.34 units on a scaleStandard Error 33.6
p-value: >0.0595% CI: [-8.02, 10.46]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)General Self-Efficacy Scale (GSES)Baseline33.97 units on a scaleStandard Error 5.1
Usual Care (Arm 1)General Self-Efficacy Scale (GSES)6 months34.74 units on a scaleStandard Error 4.9
Usual Care (Arm 1)General Self-Efficacy Scale (GSES)12 months35.07 units on a scaleStandard Error 5.1
Usual Care (Arm 1)General Self-Efficacy Scale (GSES)18 months (final)35.1 units on a scaleStandard Error 5.1
Intervention (Arm 2)General Self-Efficacy Scale (GSES)18 months (final)34.04 units on a scaleStandard Error 5.9
Intervention (Arm 2)General Self-Efficacy Scale (GSES)Baseline34.17 units on a scaleStandard Error 5.5
Intervention (Arm 2)General Self-Efficacy Scale (GSES)12 months34.38 units on a scaleStandard Error 5.7
Intervention (Arm 2)General Self-Efficacy Scale (GSES)6 months34.34 units on a scaleStandard Error 5.6
p-value: >0.0595% CI: [-2.04, 0.29]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)Health Utilities Index (HUI3)Baseline0.48 units on a scaleStandard Deviation 0.3
Usual Care (Arm 1)Health Utilities Index (HUI3)6 months0.46 units on a scaleStandard Deviation 0.3
Usual Care (Arm 1)Health Utilities Index (HUI3)12 months0.44 units on a scaleStandard Deviation 0.3
Usual Care (Arm 1)Health Utilities Index (HUI3)18 months (final)0.40 units on a scaleStandard Deviation 0.3
Intervention (Arm 2)Health Utilities Index (HUI3)18 months (final)0.40 units on a scaleStandard Deviation 0.3
Intervention (Arm 2)Health Utilities Index (HUI3)Baseline0.43 units on a scaleStandard Deviation 0.3
Intervention (Arm 2)Health Utilities Index (HUI3)12 months0.42 units on a scaleStandard Deviation 0.3
Intervention (Arm 2)Health Utilities Index (HUI3)6 months0.44 units on a scaleStandard Deviation 0.3
p-value: >0.0595% CI: [-0.04, 0.08]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)Medical Outcomes Study (MOS)Baseline3.91 units on a scaleStandard Error 0.9
Usual Care (Arm 1)Medical Outcomes Study (MOS)6 months3.93 units on a scaleStandard Error 0.9
Usual Care (Arm 1)Medical Outcomes Study (MOS)12 months3.91 units on a scaleStandard Error 0.9
Usual Care (Arm 1)Medical Outcomes Study (MOS)18 months (final)3.94 units on a scaleStandard Error 0.9
Intervention (Arm 2)Medical Outcomes Study (MOS)18 months (final)4.03 units on a scaleStandard Error 0.7
Intervention (Arm 2)Medical Outcomes Study (MOS)Baseline4.07 units on a scaleStandard Error 0.8
Intervention (Arm 2)Medical Outcomes Study (MOS)12 months4.00 units on a scaleStandard Error 0.8
Intervention (Arm 2)Medical Outcomes Study (MOS)6 months3.91 units on a scaleStandard Error 0.8
p-value: >0.0595% CI: [-0.34, 0.1]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)Patient Assessement of Care for Chronic Conditions (PACIC)Baselin2.34 units on a scaleStandard Error 0.9
Usual Care (Arm 1)Patient Assessement of Care for Chronic Conditions (PACIC)6 months2.28 units on a scaleStandard Error 0.8
Usual Care (Arm 1)Patient Assessement of Care for Chronic Conditions (PACIC)12 months2.32 units on a scaleStandard Error 0.8
Usual Care (Arm 1)Patient Assessement of Care for Chronic Conditions (PACIC)18 months (final)2.37 units on a scaleStandard Error 0.8
Intervention (Arm 2)Patient Assessement of Care for Chronic Conditions (PACIC)18 months (final)2.30 units on a scaleStandard Error 0.8
Intervention (Arm 2)Patient Assessement of Care for Chronic Conditions (PACIC)Baselin2.15 units on a scaleStandard Error 0.8
Intervention (Arm 2)Patient Assessement of Care for Chronic Conditions (PACIC)12 months2.28 units on a scaleStandard Error 0.8
Intervention (Arm 2)Patient Assessement of Care for Chronic Conditions (PACIC)6 months2.16 units on a scaleStandard Error 0.7
p-value: >0.0595% CI: [0, 0.34]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)Patient Healthcare Questionnaire-9 (PHQ-9)Baseline12.33 units on a scaleStandard Error 4.4
Usual Care (Arm 1)Patient Healthcare Questionnaire-9 (PHQ-9)6 months12.96 units on a scaleStandard Error 4.8
Usual Care (Arm 1)Patient Healthcare Questionnaire-9 (PHQ-9)12 months12.44 units on a scaleStandard Error 4.2
Usual Care (Arm 1)Patient Healthcare Questionnaire-9 (PHQ-9)18 months (final)12.21 units on a scaleStandard Error 4.8
Intervention (Arm 2)Patient Healthcare Questionnaire-9 (PHQ-9)18 months (final)12.46 units on a scaleStandard Error 4.1
Intervention (Arm 2)Patient Healthcare Questionnaire-9 (PHQ-9)Baseline14.45 units on a scaleStandard Error 3.9
Intervention (Arm 2)Patient Healthcare Questionnaire-9 (PHQ-9)12 months12.97 units on a scaleStandard Error 3.6
Intervention (Arm 2)Patient Healthcare Questionnaire-9 (PHQ-9)6 months13.22 units on a scaleStandard Error 4.2
p-value: >0.0595% CI: [-4.2, 0.24]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual Care (Arm 1)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3Baseline13 Participants
Usual Care (Arm 1)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 36 months15 Participants
Usual Care (Arm 1)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 312 months11 Participants
Usual Care (Arm 1)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 318 months (final)23 Participants
Intervention (Arm 2)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 318 months (final)11 Participants
Intervention (Arm 2)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3Baseline22 Participants
Intervention (Arm 2)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 312 months16 Participants
Intervention (Arm 2)Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 36 months13 Participants
p-value: <0.0595% CI: [-20.42, -2.62]t-test, 2 sided
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual Care (Arm 1)World Health Organization Well-Being Index (WHO-5)Baseline14.19 units on a scaleStandard Error 5.8
Usual Care (Arm 1)World Health Organization Well-Being Index (WHO-5)6 months15.02 units on a scaleStandard Error 5.7
Usual Care (Arm 1)World Health Organization Well-Being Index (WHO-5)12 months14.20 units on a scaleStandard Error 6
Usual Care (Arm 1)World Health Organization Well-Being Index (WHO-5)18 months (final)14.14 units on a scaleStandard Error 6.3
Intervention (Arm 2)World Health Organization Well-Being Index (WHO-5)18 months (final)13.45 units on a scaleStandard Error 6.5
Intervention (Arm 2)World Health Organization Well-Being Index (WHO-5)Baseline13.14 units on a scaleStandard Error 5.9
Intervention (Arm 2)World Health Organization Well-Being Index (WHO-5)12 months13.38 units on a scaleStandard Error 6.5
Intervention (Arm 2)World Health Organization Well-Being Index (WHO-5)6 months13.93 units on a scaleStandard Error 5.9
p-value: >0.0595% CI: [-1.45, 1.33]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026