A Phase 2/3 interventional study of screened and universal education in Quality of Life, Disability and Utilization of Health Care Services, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-31.
Sponsored by Centers for Disease Control and Prevention · Phase 2/3, Interventional, and Prevention
This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.
Approximately 2675 women* will be enrolled and randomized to one of 3 arms. In the first arm, participants will be screened, and if disclosing IPV, will receive information on available resources in the community. In arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. All three groups will be assessed for quality of life (SF-12;standardized and validated scale with 12 questions that measure overall health (1 item), physical functioning (2 items), role limitations due to physical health problems (4 items), bodily pain (1 item), energy/fatigue (1 item), social functioning (1 item), psychological distress (1 item), and well being (1 item) in the past 4 weeks; items are summed to form a physical health composite scale and a mental health composite scale; each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state); disability; and utilization of health care and IPV services at baseline and at a 12 month follow-up. A pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies.
*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% IPV (+) rate and 30% lost-to-follow-up rate.
Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Screened w/4 questions on intimate partner violence; if positive, receives referral information
Other: screened
all participants receive partner violence referral information
Behavioral: universal education
no screen and no referral
Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
receives referral information
Quality of Life, Physical Health Composite
Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, \& Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health-general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)-during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
Time frame: at one-year follow-up
Quality of Life, Mental Health Composite
Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, \& Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health-general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)-during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
Time frame: past 30 days
Utilization of Health Care
number of ambulatory care visits
Time frame: during past year
Disability
days lost from housework
Time frame: one year follow-up
May, 2009-April, 2010 at 10 primary health care clinics in Chicago
| Milestone | Screened & Referred | Universal Education (All Referred) | Control |
|---|---|---|---|
| Started | 909 | 893 | 898 |
| Completed | 801 | 772 | 791 |
| Not completed | 108 | 121 | 107 |
| Withdrew: Lost to follow-up | 98 | 108 | 96 |
| Withdrew: Death | 4 | 3 | 3 |
| Withdrew: Withdrawal by subject | 2 | 7 | 5 |
| Withdrew: Incarcerated, impaired, incomplete | 4 | 3 | 3 |
Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, \& Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health-general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)-during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
| units on a scale | Screened & Referred | Universal Education (All Referred) | Control |
|---|---|---|---|
| Quality of Life, Physical Health Composite | 46.8 (46.1 to 47.4) | 46.4 (45.8 to 47.1) | 47.2 (46.5 to 47.8) |
number of ambulatory care visits
| visits | Screened & Referred | Universal Education (All Referred) | Control |
|---|---|---|---|
| Utilization of Health Care | 5.4 (3.8 to 7.0) | 5.7 (4.1 to 7.3) | 5.9 (4.3 to 7.4) |
days lost from housework
| days | Screened & Referred | Universal Education (All Referred) | Control |
|---|---|---|---|
| Disability | 1.9 (1.6 to 2.3) | 2.2 (1.8 to 2.5) | 1.9 (1.6 to 2.3) |
Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, \& Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health-general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)-during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.
| units on a scale | Screened & Referred | Universal Education (All Referred) | Control |
|---|---|---|---|
| Quality of Life, Mental Health Composite | 48.3 (47.5 to 49.1) | 48.0 (47.2 to 48.9) | 47.8 (47.0 to 48.6) |
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Screened & Referred | — | 0/801 (0%) | 0/801 (0%) |
| Universal Education (All Referred) | — | 0/772 (0%) | 0/772 (0%) |
| Control | — | 0/791 (0%) | 0/791 (0%) |
| Age Continuous(years) | Screened & Referred | Universal Education (All Referred) | Control | Total |
|---|---|---|---|---|
| Mean | 39 ± 15 | 38.3 ± 14.8 | 38.7 ± 15.1 | 38.7 ± 14.9 |
| Sex: Female, Male(Participants) | Screened & Referred | Universal Education (All Referred) | Control | Total |
|---|---|---|---|---|
| Female | 909 | 893 | 898 | 2700 |
| Male | 0 | 0 | 0 | 0 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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