Spinal Cord InjuriesNCT04872569
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)
A study testing Decision-making tool in people with Spinal Cord Injuries and Pregnancy Related, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Cord Injuries, Pregnancy Related
- What is being tested?
- Decision-making tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 11 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury (traumatic or non-traumatic)
- Need for assistance with daily life activities and/or personal care; women with mild, moderate or severe severity will be eligible
- actively planning or in the process of making a decision about whether or not to get pregnant in the near future
Who cannot join
- No plans for getting pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
Read the detailed description
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
- Conditions
- Spinal Cord Injuries, Pregnancy Related
- Being tested
- Decision-making tool
- Keywords
- Decision tool
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-making toolBehavioural
Participants will be directed to use the decision tool for 3 months using it at their own pace.
The tool covers topics relevant to women with disabilities in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.
| Study group | Role | What they receive |
|---|---|---|
| Decision-making tool | Experimental | Women will receive the decision making tool and use for a 3 month period. Receives: Behavioral: Decision-making tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Decisional Conflict Scale Score - Values Clarity Sub-scale
The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Values Clarity sub-scale refers to how much a respondent is clear about the values that guide their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree [5] to strongly disagree [1]) and summed for a total score range of 3 to 15. Higher scores represent greater clarity of values.
Measured: 12 weeks
Final Decisional Conflict Scale Score - Support Sub-scale
The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Support for Decision Making sub-scale refers to how much support a respondent has from others about their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree [5] to strongly disagree [1]) and summed for a total score range of 3 to 15. Higher scores represent greater support for decision-making.
Measured: 12 weeks
Final Decisional Conflict Scale Score - Uncertainty Sub-scale
The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Uncertainty about the decision sub-scale refers to how much a respondent is uncertain about the decision. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree [5] to strongly disagree [1]) and summed for a total score range of 3 to 15. Higher scores represent greater certainty about the decision.
Measured: 12 weeks
Final Readiness to Make a Choice in Stage of Decision-Making Scale
The Stage of Decision Making is a single item self-report measure. The options range from "haven't begun to think about choices" to "have already made a decision and unlikely to change my mind". The instructions were modified to refer to pregnancy and excluded the first two options of not having begun to think about choices given inclusion criteria. For this study, the scale ranged from 1 (are considering the decision now) to 4 (have already made a decision and am unlikely to change my mind). A higher score reflects greater readiness to make a decision.
Measured: 12 weeks
Secondary outcomes (3)
Feasibility - Acceptability
Acceptability of decision making tool is refers to whether the intervention is agreeable or satisfactory. In this study we measured this by self-report. We used 13 items that measured the presentation of information of the tool rated on Likert scales ranging from 1 (poor) to 4 (excellent) which are summed across all items. Possible scores can range from 13 to 52, with higher scores reflecting better information presentation.
Measured: 12 weeks
Feasibility - Demand
Demand refers to the likelihood of using an intervention after the study is over. For this study, it is a single item rated on Likert scales of 1 (definitely not likely) to 5 (very likely). Higher scores indicate a higher likelihood of using the tool after the study is over.
Measured: 12 weeks
Feasibility - Ease of Use
Ease of use refers to how easy an intervention is to use. In this study, we measures ease of use of the tool with a self-report, single item rated on Likert scales ranging from 1 (very hard) to 5 (very easy). A higher rating means the tool was considered easier to use.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start28 Jul 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Claire Z. Kalpakjian, University of Michigan
- Investigators
- Claire Kalpakjian, PhD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872569
- Sponsor's protocol ID
- HUM00194755
- Status last verified
- Apr 2023
- First submitted
- 29 Apr 2021
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04872569
- Acronym / sponsor ID
- HUM00194755
- Conditions
- Spinal Cord Injuries, Pregnancy Related
- Keywords
- Decision tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Posted 16 Jan 2024
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 project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
Detailed description
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision-making tool | Experimental | Behavioral: Decision-making toolWomen will receive the decision making tool and use for a 3 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal cord injury (traumatic or non-traumatic)
- Need for assistance with daily life activities and/or personal care; women with mild, moderate or severe severity will be eligible
- actively planning or in the process of making a decision about whether or not to get pregnant in the near future
Key exclusion criteria (1 listed)
- No plans for getting pregnant
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 |
|---|---|---|
| Decision-making toolParticipants will be directed to use the decision tool for 3 months using it at their own pace. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support. | Behavioural | Decision-making tool |
Primary outcome
Final Decisional Conflict Scale Score - Values Clarity Sub-scale
Time frame: 12 weeks
The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Values Clarity sub-scale refers to how much a respondent is clear about the values that guide their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree [5] to strongly disagree [1]) and summed for a total score range of 3 to 15. Higher scores represent greater clarity of values.
Final Decisional Conflict Scale Score - Support Sub-scale
Time frame: 12 weeks
The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Support for Decision Making sub-scale refers to how much support a respondent has from others about their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree [5] to strongly disagree [1]) and summed for a total score range of 3 to 15. Higher scores represent greater support for decision-making.
Final Decisional Conflict Scale Score - Uncertainty Sub-scale
Time frame: 12 weeks
The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Uncertainty about the decision sub-scale refers to how much a respondent is uncertain about the decision. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree [5] to strongly disagree [1]) and summed for a total score range of 3 to 15. Higher scores represent greater certainty about the decision.
Final Readiness to Make a Choice in Stage of Decision-Making Scale
Time frame: 12 weeks
The Stage of Decision Making is a single item self-report measure. The options range from "haven't begun to think about choices" to "have already made a decision and unlikely to change my mind". The instructions were modified to refer to pregnancy and excluded the first two options of not having begun to think about choices given inclusion criteria. For this study, the scale ranged from 1 (are considering the decision now) to 4 (have already made a decision and am unlikely to change my mind). A higher score reflects greater readiness to make a decision.
3 secondary outcomes
Feasibility - Acceptability
Time frame: 12 weeks
Feasibility - Demand
Time frame: 12 weeks
Feasibility - Ease of Use
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Claire Kalpakjian, PhD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-making tool in people with Spinal Cord Injuries and Pregnancy Related, run by University of Michigan 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 3 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 16 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Final Decisional Conflict Scale Score - Values Clarity Sub-scale (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2024.