Women's HealthNCT00156663
Toward Gender Aware VA Healthcare: Development and Evaluation of an Intervention
A study testing Caring for Women Veterans in people with Women's Health, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The purpose of this study was to develop and evaluate an educational program intended to raise staff awareness about women veterans and their health care needs and preferences. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Caring for Women Veterans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2004to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be VHA employees who have direct or indirect contact with patients.
Who cannot join
- Employees who have no contact with patients.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: Toward Gender Aware VA Health Care: Development and Evaluation of an Intervention
The purpose of this study was to develop and evaluate an educational program intended to raise staff awareness about women veterans and their health care needs and preferences.
Read the detailed description
OBJECTIVES:
The primary objective of this project was to develop and evaluate a computerized program that would enhance Veterans Health Administration (VHA) employees� awareness of women veterans and their health-care needs. The program was designed to challenge negative stereotypes about female patients (gender-role ideology), increase empathy toward female patients� needs (gender sensitivity), and enhance knowledge regarding women veterans and aspects of their VHA care (knowledge).
DESIGN/METHODS:
Phases I involved generating content for the computerized interactive program. Phase II involved creating the 30-minute program. The Phase III evaluation of the program involved a two-group pretest�posttest�follow-up equivalent control group design at two facilities with a third facility comparison group. At the first two facilities, employees who provide either direct or ancillary care to patients were randomly assigned to either the treatment or the control group. Participants in the treatment group completed the program entitled Caring for Women Veterans. Participants in the control group and those at the third site completed a 30-minute program entitled Managing Stress. The data from the third site were included to test for infusion of the treatment effect within same-site groups. Gender awareness was evaluated at three time points using the Gender Awareness Inventory-VA (GAI-VA). Participants completed the GAI-VA several weeks prior to completing the computerized program (Time 1, n =339), immediately after completing the program (Time 2, n = 249), and approximately one month after the program (Time 3, n = 167). Participants also completed a qualitative evaluation of the program at Time 2.
STATUS:
Complete.
- Conditions
- Women's Health
- Being tested
- Caring for Women Veterans
- Keywords
- Women, Veterans, Delivery of Healthcare, Intervention Studies, United States Department of Veterans Affairs, Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring for Women VeteransBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Caring for Women Veterans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender Awareness is measured during the pre-test, immediately after the educational program, and approximately four weeks after the subject participates in the educational program.
Secondary outcomes (1)
Participants rate their enjoyment of the educational program and offer recommendations for the program as needed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dawne S Vogt, PhD BA, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MALynda A. King, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156663
- Sponsor's protocol ID
- GEN 20-057
- Status last verified
- Feb 2007
- First submitted
- 25 Aug 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vogt DS, Barry AA, King LA. Toward gender-aware health care: evaluation of an intervention to enhance care for female patients in the VA setting. J Health Psychol. 2008 Jul;13(5):624-38. doi: 10.1177/1359105308090934.
PubMed 18519436
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Gender Aware VA Health Care: Development and Evaluation of an Intervention
- ClinicalTrials.gov ID
- NCT00156663
- Acronym / sponsor ID
- GEN 20-057
- Conditions
- Women's Health
- Keywords
- Women, Veterans, Delivery of Healthcare, Intervention Studies, United States Department of Veterans Affairs, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to develop and evaluate an educational program intended to raise staff awareness about women veterans and their health care needs and preferences.
Detailed description
OBJECTIVES:
The primary objective of this project was to develop and evaluate a computerized program that would enhance Veterans Health Administration (VHA) employees� awareness of women veterans and their health-care needs. The program was designed to challenge negative stereotypes about female patients (gender-role ideology), increase empathy toward female patients� needs (gender sensitivity), and enhance knowledge regarding women veterans and aspects of their VHA care (knowledge).
DESIGN/METHODS:
Phases I involved generating content for the computerized interactive program. Phase II involved creating the 30-minute program. The Phase III evaluation of the program involved a two-group pretest�posttest�follow-up equivalent control group design at two facilities with a third facility comparison group. At the first two facilities, employees who provide either direct or ancillary care to patients were randomly assigned to either the treatment or the control group. Participants in the treatment group completed the program entitled Caring for Women Veterans. Participants in the control group and those at the third site completed a 30-minute program entitled Managing Stress. The data from the third site were included to test for infusion of the treatment effect within same-site groups. Gender awareness was evaluated at three time points using the Gender Awareness Inventory-VA (GAI-VA). Participants completed the GAI-VA several weeks prior to completing the computerized program (Time 1, n =339), immediately after completing the program (Time 2, n = 249), and approximately one month after the program (Time 3, n = 167). Participants also completed a qualitative evaluation of the program at Time 2.
STATUS:
Complete.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Caring for Women Veterans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be VHA employees who have direct or indirect contact with patients.
Key exclusion criteria (1 listed)
- Employees who have no contact with patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caring for Women Veterans | Behavioural | Arm 1 |
Primary outcome
Gender Awareness is measured during the pre-test, immediately after the educational program, and approximately four weeks after the subject participates in the educational program.
1 secondary outcome
Participants rate their enjoyment of the educational program and offer recommendations for the program as needed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 18519436Vogt DS, Barry AA, King LA. Toward gender-aware health care: evaluation of an intervention to enhance care for female patients in the VA setting. J Health Psychol. 2008 Jul;13(5):624-38. doi: 10.1177/1359105308090934.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawne S Vogt, PhD BA principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Lynda A. King, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring for Women Veterans in people with Women's Health, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender Awareness is measured during the pre-test, immediately after the educational program, and approximately four weeks after the subject participates in the educational program.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.