Decision MakingNCT02518893
Health Research Participation: Experiences and Decisions of Military Members
An observational study of Decision Making and Life Experiences, run by University of Washington at 1 site in United States.
Trial summary
The purpose of the study is to describe service members' experiences as participants in health research, including their reasons for deciding for or against research participation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Life Experiences
- What is being tested?
- Demographic Data and Interview
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Feb 2018
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Current United States military service members (active duty, reserve, or guard) of any service branch who have participated in military or civilian health care research within the past three years or who have declined research participation.
Who may be able to join
- current US military member of any branch of service at time of screening
- experience as a research participant and/or previously declined participation in at least one health research study within the past three years
- age 18-80 years
- willing to participate in this study
- willing to be interviewed
- consents to participate
Who cannot join
- people who do not meet inclusion criteria
- unable to verbally communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Mary S McCarthy, PhD
Mary S McCarthy, PhD
About this study
The purpose of the study is to describe service members' experiences as participants in health research, including their reasons for deciding for or against research participation.
Read the detailed description
Recent studies of war injuries have included as research participants US military service members returning from wars in Iraq and Afghanistan. Despite the increased demand for military relevant research, little is known about the recent experiences of service members as research participants or about their research participation decisions.
The study aims are to: 1). Describe the experiences of military service members who have participated in health research; 2). Explore the reasons military service members decide for or against participation in health research; and 3). Identify effective strategies for promoting military service members' participation in research.
Demographic data will be collected from up to 50 service members who have participated in health research or who have previously declined research participation.
Up to 40 service members will participate in individual, in-depth, semi-structured interviews in person or via telephone.
- Conditions
- Decision Making, Life Experiences
- Being tested
- Demographic Data, Interview
- Keywords
- Military Personnel, Air Force Personnel, Army Personnel, Navy Personnel, Armed Forces Personnel, Marines, Soldiers, Sailors, Airmen, Decision Making, Research Subjects, Life Experiences, Patient Participation, Refusal to Participate, Healthcare Research, Qualitative Research, Interview, Interviews, Telephone, Ethics, Research
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographic DataOther
Demographic data will be collected from up to 50 service members who have participated in health research or who have previously declined research participation.
InterviewOther
Up to 40 service members will participate in individual, in-depth, semi-structured interviews in person or via telephone.
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences of health research participation
Self-reports of health research participation experiences
Measured: Within past three years
Research participation decisions
Self-reports of research participation decisions
Measured: Within past three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- TriService Nursing Research Program, Madigan Army Medical Center, United States Naval Medical Center, San Diego
- Responsible party
- Principal investigator, Wendy Cook, University of Washington
- Investigators
- Wendy A Cook, PhD, MA, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518893
- Sponsor's protocol ID
- 48058
- Other IDs
- HU0001-14-1-TS07 (N14-P10), IRB #215029
- Status last verified
- May 2017
- First submitted
- 6 Aug 2015
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cook WA, Doorenbos AZ. Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review. Mil Med. 2017 Mar;182(3):e1580-e1587. doi: 10.7205/MILMED-D-16-00225.
PubMed 28290928Cook WA, Doorenbos AZ, Bridges EJ. Trends in Research with U.S. Military Service Member Participants: A Population-Specific ClinicalTrials.gov Review. Contemp Clin Trials Commun. 2016 Aug 15;3:122-130. doi: 10.1016/j.conctc.2016.04.006. Epub 2016 Apr 30.
PubMed 27822569Cook WA, Melvin KC, Doorenbos AZ. US Military Service Members' Reasons for Deciding to Participate in Health Research. Res Nurs Health. 2017 Jun;40(3):263-272. doi: 10.1002/nur.21785. Epub 2017 Feb 10.
PubMed 28185285
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Research Participation: Experiences and Decisions of Military Members
- ClinicalTrials.gov ID
- NCT02518893
- Acronym / sponsor ID
- 48058
- Conditions
- Decision Making, Life Experiences
- Keywords
- Military Personnel, Air Force Personnel, Army Personnel, Navy Personnel, Armed Forces Personnel, Marines, Soldiers, Sailors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- TriService Nursing Research Program, Madigan Army Medical Center, United States Naval Medical Center, San Diego
- Study start
- Apr 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 10 Aug 2015 (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 the study is to describe service members' experiences as participants in health research, including their reasons for deciding for or against research participation.
Detailed description
Recent studies of war injuries have included as research participants US military service members returning from wars in Iraq and Afghanistan. Despite the increased demand for military relevant research, little is known about the recent experiences of service members as research participants or about their research participation decisions.
The study aims are to: 1). Describe the experiences of military service members who have participated in health research; 2). Explore the reasons military service members decide for or against participation in health research; and 3). Identify effective strategies for promoting military service members' participation in research.
Demographic data will be collected from up to 50 service members who have participated in health research or who have previously declined research participation.
Up to 40 service members will participate in individual, in-depth, semi-structured interviews in person or via telephone.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Current United States military service members (active duty, reserve, or guard) of any service branch who have participated in military or civilian health care research within the past three years or who have declined research participation.
Key inclusion criteria (6 listed)
- current US military member of any branch of service at time of screening
- experience as a research participant and/or previously declined participation in at least one health research study within the past three years
- age 18-80 years
- willing to participate in this study
- willing to be interviewed
Key exclusion criteria (2 listed)
- people who do not meet inclusion criteria
- unable to verbally communicate in English
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 |
|---|---|---|
| Demographic DataDemographic data will be collected from up to 50 service members who have participated in health research or who have previously declined research participation. | Other | – |
| InterviewUp to 40 service members will participate in individual, in-depth, semi-structured interviews in person or via telephone. | Other | – |
Primary outcome
Experiences of health research participation
Time frame: Within past three years
Self-reports of health research participation experiences
Research participation decisions
Time frame: Within past three years
Self-reports of research participation decisions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 28290928Cook WA, Doorenbos AZ. Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review. Mil Med. 2017 Mar;182(3):e1580-e1587. doi: 10.7205/MILMED-D-16-00225.
- Background: PubMed 27822569Cook WA, Doorenbos AZ, Bridges EJ. Trends in Research with U.S. Military Service Member Participants: A Population-Specific ClinicalTrials.gov Review. Contemp Clin Trials Commun. 2016 Aug 15;3:122-130. doi: 10.1016/j.conctc.2016.04.006. Epub 2016 Apr 30.
- Results publication: PubMed 28185285Cook WA, Melvin KC, Doorenbos AZ. US Military Service Members' Reasons for Deciding to Participate in Health Research. Res Nurs Health. 2017 Jun;40(3):263-272. doi: 10.1002/nur.21785. Epub 2017 Feb 10.
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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.
Wendy A Cook, PhD, MA, RN principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decision Making and Life Experiences, run by University of Washington at 1 site 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy A Cook, PhD, MA, RN (360-626-3541, wacook@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences of health research participation (time frame: Within past three years). The study lists 2 primary outcomes in all. 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 NCT02518893, which also lists 3 linked publications.
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 30 May 2017.