N/A
N=66
Shared Decision Making Aid for Prosthetic Design
Amputation · Prosthesis User
Bottom Line
View on ClinicalTrials.gov: NCT04536025 ↗Enrolled (actual)
66
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Who Participated in and Completed 1 Hour Qualitative Interview Data Collection Via a Semi Structured Interview Guides — 38; 17; 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Qualitative focus group interviews (Other); Qualitative semi-structured interviews (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Participated in and Completed 1 Hour Qualitative Interview Data Collection Via a Semi Structured Interview Guides |
38; 17; 11 | — |
| PRIMARY Accuracy of the Decision Aid Prototype, as Measured in Percentage. |
96.0 | — |
| PRIMARY Comprehensibility of the Decision Aid Prototype, as Measured by a Likert Scale |
96.0 | — |
| PRIMARY Usability of the Decision Decision Aid Prototype, as Measured by a Likert Scale |
93.0 | — |
| SECONDARY Participant Preferences for Personal Preference Towards Control in a Health Decision, as Measured by the Control Preferences Scale Survey |
15.5; 15.4 | — |
| SECONDARY Perceived Ability to Find and Use Health Information, Via the eHealth Literacy Scale Survey |
41.7; 36.3 | — |
Summary
This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.
Eligibility Criteria
Group 1 Prosthetist Inclusion Criteria:
- At least 18 years of age
- Prosthetists actively providing prosthetic care to people with lower limb amputation
Group 1 Prosthetist Exclusion Criteria:
- Unable to participate in a 1 hour phone or video conference
- Non-English speaking
Group 2 Patient Inclusion Criteria:
- At least 18 years of age
- People who have a lower limb amputation
- People within 1 year since their first amputation
- Amputation levels ranging between above the ankle and below the hip
Group 2 Patient Exclusion Criteria:
- Unable to participate in a 1 hour phone or video conference
- Non-English speaking
Group 3 Expert Working Group Inclusion Criteria:
- At least 18 years of age
- People who have a lower limb amputation ranging between above the ankle and below the hip *OR* Prosthetists with at least 5 years experience providing prosthetic care to people with lower limb amputation.
Group Expert Working Group Exclusion Criteria:
- Unable to participate in a 1 hour phone or video conference
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT04536025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.