A Helping Hand Among Low-Income Patients

Depression Clinical Trial

— AHH  

Official title:

A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147522
• Other study ID #: AD-1304-7364
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2014
• Last updated: June 16, 2014
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: June 2014
• Source: University of Southern California
• Contact: Kathleen Ell, DSW
• Email: ell[@]usc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study Hypotheses (Ho) and Research Questions (RQ):

• Ho1. A Helping Hand (AHH) will significantly improve and sustain patient self-care management of depression and concurrent chronic illness management, Patient Assessment of Chronic Illness Care (PACIC) and Quality of Life vs UC at 6 and 12 months post-baseline.

• Ho2. AHH will significantly improve patient depression treatment acceptance/adherence and depression symptoms vs UC at 6 and 12 months post-baseline.

• RQ1. What is the association between depression symptoms and concurrent chronic illness status 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?

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 will 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes
• Heart Disease

Intervention

Behavioral:
• Self-care management
The behavioral intervention is provided by promotoras

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Efficacy for Managing Chronic Disease 6-item Scale	Contains items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians	baseline, 6- and 12-month follow-up	No
Primary	PHQ-9	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.	up to 12-month follow up.	No
Secondary	MOS Short-Form Health Survey (SF-12)	Norm-based scores standardized to the general U.S. population with a mean of 50, and a SD of 10 will be administered at baseline and follow-up calls. The SF-12 includes one measure of pain impact that asks respondents to rate pain interference with normal work on a scale from none (1) to extremely (5).	baseline, 6- and 12-month follow-up	No