Depression Clinical Trial
— LIFE-DMOfficial title:
LIFE-DM Implementation Study: A Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
NCT number | NCT04218214 |
Other study ID # | 2017-0716 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 7, 2017 |
Est. completion date | March 31, 2019 |
Verified date | November 2019 |
Source | RAND |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is an implementation project to develop a model to support implementation of LIFE-DM, an evidence-based practice (EBP) program that integrates depression management with microfinance services to address both poverty and depression among low-income women in Vietnam. This evaluation is a mixed methods study that will 1) describe the development of community-partnered implementation process, 2) study the effectiveness of the training and implementation support plan on provider and patient outcomes, and 3) identify factors that impact implementation success.
Status | Completed |
Enrollment | 141 |
Est. completion date | March 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - depression - based on Patient Health Questionnaire Total Score = > 9 - low-income - female - ages 18 - 60 Exclusion Criteria: - psychosis risk - mania risk - substance abuse risk - high suicide risk - physical disabilities - significant cognitive impairments |
Country | Name | City | State |
---|---|---|---|
Vietnam | Commune Health Stations | Da Nang | |
Vietnam | Commune Health Stations | Hu? | Thua Thien Hue |
Lead Sponsor | Collaborator |
---|---|
RAND | Basic Needs Vietnam, Danang Psychiatric Hospital, Grand Challenges Canada |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Provider Adoption of LIFE-DM and Depression Care - Count | Delivery of LIFE-DM and depression care components (Counts of depression care components delivered - # of screening, assessment, LIFEDM, individual therapy, medication, loans) | one year | |
Primary | Provider Adoption of LIFE-DM and Depression Care - Percentage | Delivery of LIFE-DM and depression care components (% of depression care components delivered - screening, assessment, LIFEDM, individual therapy, medication, loans based on eligible cases) | one year | |
Primary | Patient Depression Scores (PHQ) Change from Baseline to 6 month | Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. | 0, 6 months | |
Secondary | Provider Participation | Provider Participation in Training Activities (Count / % of workshop attendance, supervision meetings, and learning collaborative meetings) | 0-12 months | |
Secondary | Provider Implementation Quality | Supervisor Rated LIFE-DM session adherence and quality. Supervision of groups involve observation of group facilitation by supervisors, who provide adherence and quality ratings of sessions. Each item is assessed on a 4 point scale - 0 (did not do), 1 (delivered but poor), 2 (average), and 3 (excellent). The items are averaged to provide a session specific score of adherence and quality. Session adherence / quality scores are used to compute provider level adherence and quality averages. Each supervisor was expected to provide ratings for a minimum of 3 assessments out of the 12 group sessions. These session ratings are used to compute the average adherence and quality score for each provider. | throughout the study implementation period, about 1 year | |
Secondary | Implementation Barriers and Facilitators | Qualitative Interviews of Providers and Program Staff to Assess Barriers and Facilitators of Implementation | one year | |
Secondary | Change in Patient Functioning | Patient - SF-12 - Change in functioning from baseline to 6 months. The SF-12 Health Survey is a 12-item subset of the SF-36v2™ that measures the same eight domains of health (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It is a brief, reliable measure of overall health status. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years | 0 and 6 months | |
Secondary | Change in Patient Family Functioning | Patient - McMaster Family Functioning Scale - Change from baseline to 6 months. This is a 12 item scale (on a 4 point scale). the average score across items is used to determine the degree of problematic family functioning. A score of 2.00 or above indicates problematic family functioning. The higher the score, the more problematic the family member perceives the family's overall functioning. | 0 and 6 months |
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