Clinical trial NCT02147522: A Helping Hand Among Low-Income Patients
Official title: A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Diabetes
Heart Disease
Keywords: community health worker
promotoras
self-care behaviors activation
depression
low-income patients
safety-net care
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline
timeFrame: 6- and12-month follow-ups
Secondary outcomes:
measure: Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)
timeFrame: baseline, 6- and 12-month follow-ups
Other outcomes:
measure: Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score
timeFrame: baseline, 6- and 12-month follow-ups
Locations:
city: El Monte
country: United States
facility: El Monte Comprehensive Health Center
state: California
city: Los Angeles
country: United States
facility: H. Claude Hudson Comprehensive Health Center
state: California
city: Los Angeles
country: United States
facility: Edward R. Roybal Comprehensive Health Center
state: California
Study officials:
affiliation: USC Suzanne Dworak-Peck School of Social Work
name: Kathleen Ell, DSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ell 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.
citation: Ell 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.