A Helping Hand Among Low-Income Patients

Not Applicable

Completed

• Conditions: Diabetes; Depression; Heart Disease
• Interventions: Behavioral: Self-care management

• Registration Number: NCT02147522
• Lead Sponsor: University of Southern California

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?

Detailed Description

Major depression, plus other chronic illness such as diabetes, coronary heart disease and heart failure is common among low-income, culturally diverse safety net care patients. Unfortunately, many of these patients are uncomfortable about either asking their doctor questions about their illness and treatment options and their illness self-care or informing their doctors about their treatment preferences. Lack of strong engagement with medical providers occurs because patients believe they lack the knowledge to ask questions or to understand and follow recommended self-care and their concern that their medical provider lacks understanding of their treatment preferences. These factors often result in patient worry, poor adherence to prescribed treatment, and worsening illness status and even early death. The study will be conducted by a university, the Los Angeles County Department of Health Services (DHS) and a community health worker organization research team. The study will be conducted within two DHS Patient-Centered Medical Home clinics, with each patient having a designated primary care team of physician, nurse, social worker and medical assistant. Study patients with major depression and other illnesses face numerous self-care management barriers: managing concurrent symptoms (depression, pain, anxiety etc.) and cultural influences (depression stigma, diet), difficulty in navigating primary and specialty doctor and treatment plans, while at the same time experiencing daily social and economic stress. The randomized comparative effectiveness study plans to recruit 350 patients with major depression and a concurrent chronic illness (i.e., diabetes, heart failure, coronary heart disease) from two DHS PCMH community health centers. To enhance patient-centered research community partnerships, patients will be provided A Helping Hand (AHH) in which a community organization- based promotora aims to activate patient-centered depression self-care training and practical assistance to: a) improve and personalize major depression self-care (e.g., medication or psychotherapy preference, treatment adherence, fatigue, pain, diet, activity, stress management, family/caregiver communication); b) activate patient-provider communication, clinic appointment keeping and treatment coordination; and c) and facilitate patient navigation and receipt of needed community resources. AHH aims to improve patient self-care management and patient-provider care management relationships among underserved low-income patients, who must simultaneously cope with major depression and chronic co-morbid physical illness. Study objectives aim to determine: 1) whether community health worker promotora care management training improves patient-centered outcomes, such as self-care need and management, treatment adherence, symptom improvement, and care satisfaction over the usual team care; 2) depression symptom improvement; and 3) patient hospitalizations and ER visits frequency.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-26
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2016-11-30
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Results First Posted: 2017-08-02
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A Helping Hand (AHH)	Self-care management	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.

Primary Outcome Measures

Name	Time	Method
Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)	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.

Trial Locations

Locations (3)

El Monte Comprehensive Health Center; 🇺🇸 El Monte, California, United States

Edward R. Roybal Comprehensive Health Center; 🇺🇸 Los Angeles, California, United States

H. Claude Hudson Comprehensive Health Center; 🇺🇸 Los Angeles, California, United States