Trial Outcomes & Findings for MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases (NCT NCT04879745)
NCT ID: NCT04879745
Last Updated: 2024-04-30
Results Overview
Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
COMPLETED
NA
45 participants
T2 (within 24 hours of intervention and appointment)
2024-04-30
Participant Flow
Participant milestones
| Measure |
Decision Aid Users
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
10
|
|
Overall Study
Post-intervention Assessment
|
31
|
9
|
|
Overall Study
COMPLETED
|
31
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Decision Aid Users
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases
Baseline characteristics by cohort
| Measure |
Decision Aid Users
n=35 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=10 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
33.23 years
n=99 Participants
|
28.80 years
n=107 Participants
|
32.825 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
10 participants
n=107 Participants
|
45 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: T2 (within 24 hours of intervention and appointment)Population: 30 of 31 decision aid users completed the AIM.
Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
Outcome measures
| Measure |
Decision Aid Users
n=30 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=9 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Acceptability of Intervention
|
4.45 score on a scale
Standard Deviation .59
|
3.97 score on a scale
Standard Deviation .65
|
PRIMARY outcome
Timeframe: T2 (within 24 hours of intervention and appointment)Population: 30 of the 31 Decision Aid users completed the IAM.
The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.
Outcome measures
| Measure |
Decision Aid Users
n=30 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=9 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Intervention Appropriateness Measure
|
4.48 score on a scale
Standard Deviation .61
|
4.11 score on a scale
Standard Deviation .85
|
PRIMARY outcome
Timeframe: T2 (within 24 hours of intervention and appointment)Population: 30 of the original 31 Decision Aid Users completed the SUS Measure.
Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores \>80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.
Outcome measures
| Measure |
Decision Aid Users
n=30 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=9 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
System Usability Scale
|
83.06 score on a scale
Standard Deviation 15.67
|
79.32 score on a scale
Standard Deviation 14.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)Rheumatology-specific reproductive health knowledge was assessed via ReproKnow, a measure developed and preliminarily validated by our team that covers domains of contraception safety and efficacy, pregnancy management, pre-conception planning, medication safety, fertility; a score of nine indicates the highest level of reproductive knowledge
Outcome measures
| Measure |
Decision Aid Users
n=31 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=9 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)
T2
|
7.27 number of correct responses
Standard Deviation 1.17
|
7.11 number of correct responses
Standard Deviation 2.50
|
|
Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)
T0
|
5.77 number of correct responses
Standard Deviation 1.76
|
5.44 number of correct responses
Standard Deviation 2.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)Self-reported efficacy in communicating with providers was assessed using a modified version of the validated five-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale. Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Aggregate score is calculated by taking the individual item scores together and dividing by 5, with higher score indicating higher perceived efficacy in communicating with providers.
Outcome measures
| Measure |
Decision Aid Users
n=31 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=9 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Perceived Efficacy in Patient-Physician Interactions
T2
|
4.07 score on a scale
Standard Deviation 0.82
|
3.98 score on a scale
Standard Deviation .98
|
|
Perceived Efficacy in Patient-Physician Interactions
T0
|
3.47 score on a scale
Standard Deviation 1.19
|
3.73 score on a scale
Standard Deviation .92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: T3 (three months post-intervention)Population: Pamphlet users did not complete T3 assessment. 30 Decision aids users completed T3 assessment.
Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.
Outcome measures
| Measure |
Decision Aid Users
n=30 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Participant Number of Pregnancies During Study
Pregnant
|
1 Participants
|
0 Participants
|
|
Participant Number of Pregnancies During Study
Not pregnant
|
29 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: T2 (within 24 hours of intervention and appointment)Three-item measure. Did you talk to your rheumatologist about family planning today- yes/no; Did you make a decision related to family planning- yes/no; what was the family planning decision you made today? (Not Reported)
Outcome measures
| Measure |
Decision Aid Users
n=31 Participants
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
Pamphlet Users
n=9 Participants
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
|
|---|---|---|
|
Quantity and Quality of Reproductive Health Conversation With Rheumatologist
Did you talk to your Rheumatologist today about family planning? · Yes
|
17 Participants
|
4 Participants
|
|
Quantity and Quality of Reproductive Health Conversation With Rheumatologist
Did you talk to your Rheumatologist today about family planning? · No
|
14 Participants
|
5 Participants
|
|
Quantity and Quality of Reproductive Health Conversation With Rheumatologist
Did you make a decision related to family planning? · Yes
|
6 Participants
|
1 Participants
|
|
Quantity and Quality of Reproductive Health Conversation With Rheumatologist
Did you make a decision related to family planning? · No
|
25 Participants
|
8 Participants
|
Adverse Events
Decision Aid Users
Pamphlet Users
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mehret Birru Talabi
University of Pittsburgh Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place