Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02147522
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2014-05-19
Brief Title:
A Helping Hand Among Low-Income Patients
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Helping Hand AHH to Activate Patient-Centered Depression Care Among Low-Income Patients
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AHH
Brief Summary:
Study Hypotheses Ho and Research Questions RQ
Ho1 AHH will significantly improve patient depression treatment acceptanceadherence 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 clinicorganizational 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
Ho1 AHH will significantly improve patient depression treatment acceptanceadherence 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 clinicorganizational 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 ie 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 eg medication or psychotherapy preference treatment adherence fatigue pain diet activity stress management familycaregiver 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None