A Helping Hand Among Low-Income Patients (AHH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02147522|
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Study Hypotheses (Ho) and Research Questions (RQ):
- Ho1. AHH will significantly improve patient depression treatment acceptance/adherence and depression symptoms vs UC at 6 and 12 months post-baseline.
- Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs UC at 6 and 12 months post-baseline.
- RQ1. What is the association between depression symptoms and concurrent chronic illness self-care management over time by group?
- RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic appointment-keeping?
- RQ3. Will patient care satisfaction and reported barriers to self-care management vary by study group?
- RQ4. What factors are identified via qualitative assessments of patients, promotoras, Department of Health Services (DHS) medical and social work providers, and DHS clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and suggested modifications of the AHH promotora delivery model?
- RQ5. What potential technology applications would enhance promotoras delivering patient-centered self-care training and resource navigation, communicating and integrating care with DHS, and disseminating AHH?
|Condition or disease||Intervention/treatment||Phase|
|Depression Diabetes Heart Disease||Behavioral: Self-care management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||348 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: A Helping Hand (AHH)
Participants receive DHS-PCMH usual care from their respective county health clinic providers plus the AHH intervention provided by study promotoras. AHH intervention includes 6 weekly in-person or via-telephone intervention sessions followed by 3 monthly telephone booster sessions aimed at reducing the burden and strain on patients, families, and care providers by assessing, enhancing, and facilitating patient depression and co-morbid illness self-care management, and activating patient communication with clinic medical providers.
Behavioral: Self-care management
AHH behavioral intervention is provided by promotoras
No Intervention: Usual Care (UC)
Participants receive DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers.
PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics.
- Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline [ Time Frame: 6- and12-month follow-ups ]The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment.
- Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS) [ Time Frame: baseline, 6- and 12-month follow-ups ]The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health.
- Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score [ Time Frame: baseline, 6- and 12-month follow-ups ]The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147522
|United States, California|
|El Monte Comprehensive Health Center|
|El Monte, California, United States, 91731|
|H. Claude Hudson Comprehensive Health Center|
|Los Angeles, California, United States, 90007|
|Edward R. Roybal Comprehensive Health Center|
|Los Angeles, California, United States, 90022|
|Principal Investigator:||Kathleen Ell, DSW||USC Suzanne Dworak-Peck School of Social Work|