N/A N=348 Randomized Single-blind Supportive Care

A Helping Hand Among Low-Income Patients

Depression · Diabetes · Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT02147522 ↗

Enrolled (actual)

348

Serious AEs

1.2%

Results posted

Aug 2017

Primary outcome: Primary: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline — 69; 68; 67; 60 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Self-care management (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Southern California
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline	69; 68; 67; 60	—
SECONDARY Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)	38.28; 38.27; 37.85; 36.33; 37.63; 37.1	—

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?

Eligibility Criteria

Inclusion Criteria

age >=18 years, have a phone, meet PHQ-9 score of 10 or more, and have concurrent diabetes, CHD, or HF.

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02147522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.