Trial Outcomes & Findings for A Helping Hand Among Low-Income Patients (NCT NCT02147522)
NCT ID: NCT02147522
Last Updated: 2017-08-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
348 participants
Primary outcome timeframe
6- and12-month follow-ups
Results posted on
2017-08-02
Participant Flow
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.
Participant milestones
| Measure |
A Helping Hand (AHH)
Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone 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.
|
Usual Care (UC)
Participants received DHS Patient Centered Medical Home (PCMH) clinic 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.
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
170
|
|
Overall Study
COMPLETED
|
122
|
122
|
|
Overall Study
NOT COMPLETED
|
56
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Helping Hand Among Low-Income Patients
Baseline characteristics by cohort
| Measure |
A Helping Hand (AHH)
n=178 Participants
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.
|
Usual Care (UC)
n=170 Participants
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.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.77 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
56.31 years
STANDARD_DEVIATION 8.47 • n=7 Participants
|
56.54 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
176 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
178 participants
n=5 Participants
|
170 participants
n=7 Participants
|
348 participants
n=5 Participants
|
|
Depression Severity, Categorial
Moderate, PHQ-9 score 10-14
|
71 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Depression Severity, Categorial
Moderately severe, PHQ-9 score 15-19
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Depression Severity, Categorial
Severe, PHQ-9 score 20+
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6- and12-month follow-upsPopulation: 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.
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.
Outcome measures
| Measure |
A Helping Hand (AHH)
n=130 Participants
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.
|
Usual Care (UC)
n=133 Participants
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.
|
|---|---|---|
|
Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline
6-Month
|
69 Participants
|
68 Participants
|
|
Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline
12-Month
|
67 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: baseline, 6- and 12-month follow-upsPopulation: Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).
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.
Outcome measures
| Measure |
A Helping Hand (AHH)
n=178 Participants
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.
|
Usual Care (UC)
n=170 Participants
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.
|
|---|---|---|
|
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)
Baseline
|
38.28 units on a scale
Standard Deviation 10.45
|
38.27 units on a scale
Standard Deviation 11.14
|
|
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)
6-Month
|
37.85 units on a scale
Standard Deviation 11.2
|
36.33 units on a scale
Standard Deviation 11.35
|
|
Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)
12-Month
|
37.63 units on a scale
Standard Deviation 10.73
|
37.1 units on a scale
Standard Deviation 11.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6- and 12-month follow-upsPopulation: Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).
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.
Outcome measures
| Measure |
A Helping Hand (AHH)
n=178 Participants
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.
|
Usual Care (UC)
n=170 Participants
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.
|
|---|---|---|
|
Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score
Baseline
|
6.22 units on a scale
Standard Deviation 3.1
|
5.8 units on a scale
Standard Deviation 2.62
|
|
Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score
6-Month
|
7.2 units on a scale
Standard Deviation 2.73
|
6.85 units on a scale
Standard Deviation 2.89
|
|
Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score
12-Month
|
7.23 units on a scale
Standard Deviation 2.68
|
6.79 units on a scale
Standard Deviation 3.0
|
Adverse Events
A Helping Hand (AHH)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (UC)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
A Helping Hand (AHH)
n=178 participants at risk
Participants received PCMH depression care services from their respective county health clinic providers plus the AHH intervention. Promotoras provided 6 weekly in-person or via-telephone intervention followed by 3 monthly telephone 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.
|
Usual Care (UC)
n=170 participants at risk
Participants received DHS Patient Centered Medical Home (PCMH) clinic 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.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/178 • 1 year
The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
0.59%
1/170 • Number of events 1 • 1 year
The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
|
General disorders
Hospitalization
|
0.56%
1/178 • Number of events 1 • 1 year
The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
0.59%
1/170 • Number of events 1 • 1 year
The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
|
General disorders
Resided in a nursing home
|
0.56%
1/178 • Number of events 1 • 1 year
The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
0.00%
0/170 • 1 year
The study intervention provided only educational sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
Other adverse events
Adverse event data not reported
Additional Information
Kathleen Ell, DSW, Principle Investigator
USC Suzanne Dworak-Peck School of Social Work
Phone: 760-399-0263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place