Trial Outcomes & Findings for Realizing Opportunities for Self Empowerment (NCT NCT02087956)
NCT ID: NCT02087956
Last Updated: 2019-01-07
Results Overview
We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment. The WHOQOL-bref contains five Likert style response scales: "very poor to very good" (evaluation scale), "very dissatisfied to very satisfied" (evaluation scale), "none to extremely" (intensity scale), "none to complete" (capacity scale) and "never to always" (frequency scale).The mean score in each domain indicates the individual's perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130.
COMPLETED
NA
223 participants
Post treatment (4 months after enrollment)
2019-01-07
Participant Flow
Participant milestones
| Measure |
Personalized Support for Progress (PSP)
In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.
Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
|
Enhanced Screening and Referral (ESR)
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
112
|
|
Overall Study
COMPLETED
|
105
|
107
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
Baseline characteristics by cohort
| Measure |
Personalized Support for Progress (PSP)
n=111 Participants
In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.
Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
|
Enhanced Screening and Referral (ESR)
n=112 Participants
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
29.7 years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
30.5 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
30.1 years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
223 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
AA/Black
|
69 Participants
n=93 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
68 Participants
n=4 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
137 Participants
n=27 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
|
Race/Ethnicity, Customized
White/Caucasian
|
26 Participants
n=93 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
27 Participants
n=4 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
53 Participants
n=27 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
19 Participants
n=93 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
24 Participants
n=4 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
43 Participants
n=27 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
|
Race/Ethnicity, Customized
Other (Native American, Asian, Hawaiian)
|
4 Participants
n=93 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
8 Participants
n=4 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
12 Participants
n=27 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
|
Race/Ethnicity, Customized
Biracial/More than one race
|
7 Participants
n=93 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
11 Participants
n=4 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
18 Participants
n=27 Participants • Our sample doesn't add up to 100% because our participant could check "all that apply" for race/ethnicity.
|
|
Region of Enrollment
United States
|
111 participants
n=93 Participants
|
112 participants
n=4 Participants
|
223 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Post treatment (4 months after enrollment)Population: Results are presented for WHO-QOL total score. We had attrition of about 5% throughout the study, therefore number of analyzed at post treatment differs from initial number of participants.
We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment. The WHOQOL-bref contains five Likert style response scales: "very poor to very good" (evaluation scale), "very dissatisfied to very satisfied" (evaluation scale), "none to extremely" (intensity scale), "none to complete" (capacity scale) and "never to always" (frequency scale).The mean score in each domain indicates the individual's perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130.
Outcome measures
| Measure |
Personalized Support for Progress (PSP)
n=111 Participants
In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.
Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
|
Enhanced Screening and Referral (ESR)
n=112 Participants
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
|
|---|---|---|
|
Patient Quality of Life
baseline
|
79.51 units on a scale
Standard Deviation 13.82
|
76.91 units on a scale
Standard Deviation 13.70
|
|
Patient Quality of Life
post treatment
|
82.70 units on a scale
Standard Deviation 14.14
|
78.85 units on a scale
Standard Deviation 15.57
|
PRIMARY outcome
Timeframe: baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)Population: We had 5% attrition throughout the study, therefore number of subjects differ at each assessment point.
Depression was measured by PHQ-9, a screen for major depressive disorder with good discriminant validity and sensitivity to change validated in Ob/Gyn settings, and with pregnant and postpartum women, and with women of color. Scale ranges 0-27. Higher the score, higher severity of depression and cutpoints of 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.
Outcome measures
| Measure |
Personalized Support for Progress (PSP)
n=111 Participants
In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.
Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
|
Enhanced Screening and Referral (ESR)
n=112 Participants
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
|
|---|---|---|
|
Depression Change Outcome Measure
baseline
|
13.92 units on a scale
Standard Deviation 3.78
|
14.74 units on a scale
Standard Deviation 4.21
|
|
Depression Change Outcome Measure
post treatment
|
10.61 units on a scale
Standard Deviation 6.43
|
12.58 units on a scale
Standard Deviation 6.56
|
|
Depression Change Outcome Measure
3 months follow-up
|
10.14 units on a scale
Standard Deviation 6.19
|
11.39 units on a scale
Standard Deviation 6.45
|
|
Depression Change Outcome Measure
6 months follow-up
|
10.21 units on a scale
Standard Deviation 6.27
|
10.36 units on a scale
Standard Deviation 6.40
|
PRIMARY outcome
Timeframe: Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)Population: We had attrition of about 5% throughout the study, therefor number of analyzed at post treatment differs from initial number of participants
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument to assess subjective satisfaction with treatment which was administered to all participants post-treatment We analyzed 4 items: CSQ1: "How would you rate the quality of service you have received?", CSQ 3: "To what extent has our program met your needs?", CSQ 6: "Have the services you received helped you to deal more effectively with your problems?" and CSQ 7: "In an overall, general sense, how satisfied are you with the service you have received?" (1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor). We are reporting on CSQ 1 outcome.
Outcome measures
| Measure |
Personalized Support for Progress (PSP)
n=106 Participants
In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.
Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
|
Enhanced Screening and Referral (ESR)
n=105 Participants
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
|
|---|---|---|
|
Client Satisfaction Questionnaire- 8 Items
CSQ 1. post treatment
|
1.57 units on a scale
Standard Deviation 0.65
|
1.43 units on a scale
Standard Deviation 0.65
|
|
Client Satisfaction Questionnaire- 8 Items
CSQ 1. 3 months follow-up
|
1.72 units on a scale
Standard Deviation 0.70
|
1.50 units on a scale
Standard Deviation 0.64
|
|
Client Satisfaction Questionnaire- 8 Items
CSQ 1. 6 months follow-up
|
1.63 units on a scale
Standard Deviation 0.75
|
1.41 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)Population: We had attrition of 5% throughout the study; additionally we had some missing data.
Feldhaus Partner Violence Screen is 3 items measure assessing physical abuse by partner in the past year. Scale range: 0-3; higher the score higher frequency of physical abuse.
Outcome measures
| Measure |
Personalized Support for Progress (PSP)
n=108 Participants
In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan.
Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
|
Enhanced Screening and Referral (ESR)
n=109 Participants
(ESR)- participant will receive personal report of their current needs and list of resources available in the community.
Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
|
|---|---|---|
|
Domestic Violence (Feldhaus)
DV_baseline
|
0.29 units on a scale
Standard Deviation 0.45
|
0.23 units on a scale
Standard Deviation 0.42
|
|
Domestic Violence (Feldhaus)
DV_post treatment
|
0.17 units on a scale
Standard Deviation 0.38
|
0.26 units on a scale
Standard Deviation 0.44
|
|
Domestic Violence (Feldhaus)
DV_3 months follow-up
|
0.17 units on a scale
Standard Deviation 0.38
|
0.23 units on a scale
Standard Deviation 0.42
|
|
Domestic Violence (Feldhaus)
DV_6 months follow-up
|
0.11 units on a scale
Standard Deviation 0.31
|
0.20 units on a scale
Standard Deviation 0.40
|
Adverse Events
Personalized Support for Progress (PSP)
Enhanced Screening and Referral (ESR)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place