A Helping Hand Among Low-Income Patients
AHH
A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients
1 other identifier
interventional
348
1 country
3
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Oct 2013
Typical duration for not_applicable depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
August 2, 2017
CompletedAugust 2, 2017
April 1, 2017
2.9 years
May 19, 2014
November 30, 2016
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline
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.
6- and12-month follow-ups
Secondary Outcomes (1)
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)
baseline, 6- and 12-month follow-ups
Other Outcomes (1)
Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score
baseline, 6- and 12-month follow-ups
Study Arms (2)
A Helping Hand (AHH)
EXPERIMENTALParticipants 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.
Usual Care (UC)
NO INTERVENTIONParticipants 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.
Interventions
AHH behavioral intervention is provided by promotoras
Eligibility Criteria
You may qualify if:
- age \>=18 years, have a phone, meet PHQ-9 score of 10 or more, and have concurrent diabetes, CHD, or HF.
You may not qualify if:
- current suicidal ideation,inability to speak either English or Spanish fluently, a score of 2 or greater on the CAGE 4M alcohol assessment,recent use of lithium or antipsychotic medication, and cognitive impairment precluding informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
El Monte Comprehensive Health Center
El Monte, California, 91731, United States
H. Claude Hudson Comprehensive Health Center
Los Angeles, California, 90007, United States
Edward R. Roybal Comprehensive Health Center
Los Angeles, California, 90022, United States
Related Publications (3)
Oh H, Ell K. Associations Between Changes in Depressive Symptoms and Social Support and Diabetes Management Among Low-Income, Predominantly Hispanic Patients in Patient-Centered Care. Diabetes Care. 2018 Jun;41(6):1149-1156. doi: 10.2337/dc17-2000. Epub 2018 Mar 27.
PMID: 29588293DERIVEDEll K, Aranda MP, Wu S, Oh H, Lee PJ, Guterman J. Promotora assisted depression and self-care management among predominantly Latinos with concurrent chronic illness: Safety net care system clinical trial results. Contemp Clin Trials. 2017 Oct;61:1-9. doi: 10.1016/j.cct.2017.07.001. Epub 2017 Jul 3.
PMID: 28684357DERIVEDEll K, Aranda MP, Wu S, Oh H, Lee PJ, Guterman J. Promotora assisted depression care among predominately Hispanic patients with concurrent chronic illness: Public care system clinical trial design. Contemp Clin Trials. 2016 Jan;46:39-47. doi: 10.1016/j.cct.2015.11.012. Epub 2015 Nov 17.
PMID: 26600285DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1\) patients lost follow up in intervention visits, outcome interviews; 2) community health workers activated in DHS-PCMH at the same time the AHH trial started; 3) reliance on self-reported outcomes while DHS medical records system update was delayed
Results Point of Contact
- Title
- Kathleen Ell, DSW, Principle Investigator
- Organization
- USC Suzanne Dworak-Peck School of Social Work
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Ell, DSW
USC Suzanne Dworak-Peck School of Social Work
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 26, 2014
Study Start
October 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
August 2, 2017
Results First Posted
August 2, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share