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A Helping Hand Among Low-Income Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02147522
Acronym
AHH
Enrollment
348
Registered
2014-05-26
Start date
2013-10-31
Completion date
2016-09-30
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Diabetes, Heart Disease

Keywords

community health worker, promotoras, self-care behaviors activation, depression, low-income patients, safety-net 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.

Interventions

BEHAVIORALSelf-care management

AHH behavioral intervention is provided by promotoras

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline6- and12-month follow-upsThe 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

MeasureTime frameDescription
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)baseline, 6- and 12-month follow-upsThe 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.

Other

MeasureTime frameDescription
Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Scorebaseline, 6- and 12-month follow-upsThe Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.

Countries

United States

Participant flow

Recruitment details

Patients were identified from medical charts or referred by care providers at three LAC-DHS community clinics with Patient Centered Medical Home (PCMH) care model, screened and recruited between April 2014 to May 2015.

Participants by arm

ArmCount
A Helping Hand (AHH)
Participants received 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.
178
Usual Care (UC)
Participants received DHS Patient Centered Medical Home (PCMH) clinic team usual care from their respective county health clinic providers. PCMH model has available DHS medical providers and social workers for depression care and refer patients when indicated to community mental health clinics. Problem-Solving Therapy (PST) is available in some of participating clinics.
170
Total348

Baseline characteristics

CharacteristicUsual Care (UC)TotalA Helping Hand (AHH)
Age, Continuous56.31 years
STANDARD_DEVIATION 8.47
56.54 years
STANDARD_DEVIATION 8.63
56.77 years
STANDARD_DEVIATION 8.79
Depression Severity, Categorial
Moderately severe, PHQ-9 score 15-19
73 Participants147 Participants74 Participants
Depression Severity, Categorial
Moderate, PHQ-9 score 10-14
62 Participants133 Participants71 Participants
Depression Severity, Categorial
Severe, PHQ-9 score 20+
35 Participants68 Participants33 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
168 Participants344 Participants176 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
United States
170 participants348 participants178 participants
Sex: Female, Male
Female
144 Participants296 Participants152 Participants
Sex: Female, Male
Male
26 Participants52 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1781 / 170
other
Total, other adverse events
0 / 1780 / 170
serious
Total, serious adverse events
2 / 1782 / 170

Outcome results

Primary

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

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.

Time frame: 6- and12-month follow-ups

Population: Analyses for hypothesis testing related to the evaluation of AHH effects were carried out according to the intention-to-treat rule consistent with standard practice in clinical trials.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
A Helping Hand (AHH)Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline6-Month69 Participants
A Helping Hand (AHH)Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline12-Month67 Participants
Usual Care (UC)Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline12-Month60 Participants
Usual Care (UC)Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline6-Month68 Participants
Secondary

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

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.

Time frame: baseline, 6- and 12-month follow-ups

Population: Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).

ArmMeasureGroupValue (MEAN)Dispersion
A Helping Hand (AHH)Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)12-Month37.63 units on a scaleStandard Deviation 10.73
A Helping Hand (AHH)Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)Baseline38.28 units on a scaleStandard Deviation 10.45
A Helping Hand (AHH)Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)6-Month37.85 units on a scaleStandard Deviation 11.2
Usual Care (UC)Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)Baseline38.27 units on a scaleStandard Deviation 11.14
Usual Care (UC)Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)12-Month37.1 units on a scaleStandard Deviation 11.68
Usual Care (UC)Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)6-Month36.33 units on a scaleStandard Deviation 11.35
Other Pre-specified

Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score

The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.

Time frame: baseline, 6- and 12-month follow-ups

Population: Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).

ArmMeasureGroupValue (MEAN)Dispersion
A Helping Hand (AHH)Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) ScoreBaseline6.22 units on a scaleStandard Deviation 3.1
A Helping Hand (AHH)Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score6-Month7.2 units on a scaleStandard Deviation 2.73
A Helping Hand (AHH)Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score12-Month7.23 units on a scaleStandard Deviation 2.68
Usual Care (UC)Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) ScoreBaseline5.8 units on a scaleStandard Deviation 2.62
Usual Care (UC)Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score6-Month6.85 units on a scaleStandard Deviation 2.89
Usual Care (UC)Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score12-Month6.79 units on a scaleStandard Deviation 3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026