Trial Outcomes & Findings for SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study (NCT NCT02741700)
NCT ID: NCT02741700
Last Updated: 2022-03-17
Results Overview
ULT adherence, directly measured by using MEMS (Medication Event Monitoring System) Caps at 3, 6, and 9 months (assess intervention's effect) and 12 months (assess the durability of effect)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
306 participants
Primary outcome timeframe
3, 6, 9, and 12 months
Results posted on
2022-03-17
Participant Flow
Participant milestones
| Measure |
Gout Storytelling Video
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
154
|
|
Overall Study
COMPLETED
|
126
|
135
|
|
Overall Study
NOT COMPLETED
|
26
|
19
|
Reasons for withdrawal
| Measure |
Gout Storytelling Video
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Moved out of State
|
0
|
1
|
|
Overall Study
Death
|
4
|
5
|
Baseline Characteristics
SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study
Baseline characteristics by cohort
| Measure |
Gout Storytelling Video
n=152 Participants
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
n=154 Participants
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
64 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
152 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6, 9, and 12 monthsULT adherence, directly measured by using MEMS (Medication Event Monitoring System) Caps at 3, 6, and 9 months (assess intervention's effect) and 12 months (assess the durability of effect)
Outcome measures
| Measure |
Gout Storytelling Video
n=152 Participants
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
n=154 Participants
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Medication Adherence
MEMSCap™ ULT MPR at 3-months
|
72.61 percentage of days ULT was taken
Interval 67.88 to 77.35
|
70.12 percentage of days ULT was taken
Interval 65.49 to 74.75
|
|
Medication Adherence
MEMSCap™ ULT MPR at 6-months
|
68.52 percentage of days ULT was taken
Interval 63.4 to 73.64
|
69.33 percentage of days ULT was taken
Interval 64.36 to 74.3
|
|
Medication Adherence
MEMSCap™ ULT MPR at 9-months
|
65.85 percentage of days ULT was taken
Interval 60.14 to 71.55
|
67.32 percentage of days ULT was taken
Interval 61.84 to 72.8
|
|
Medication Adherence
MEMSCap™ ULT MPR at 12-months
|
60.54 percentage of days ULT was taken
Interval 54.29 to 66.79
|
63.82 percentage of days ULT was taken
Interval 57.83 to 69.82
|
SECONDARY outcome
Timeframe: 12 monthsParticipant-reported total number of gout flares in the last 1 month
Outcome measures
| Measure |
Gout Storytelling Video
n=152 Participants
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
n=154 Participants
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Gout Flares
|
0.74 Self-reported gout flares in 1 month
Interval 0.45 to 1.02
|
0.99 Self-reported gout flares in 1 month
Interval 0.72 to 1.26
|
SECONDARY outcome
Timeframe: 12 monthsPatient satisfaction with medication on the patient questionnaire (SATMED composite score), range 0-100. The SATMED-Q contains 17 items, each scored on a 5-point Likert scale. The total composite score ranges between 0 and 68. The score was converted to a percentage as recommended (=(raw score\*100)/68); higher score = more satisfaction with medication.
Outcome measures
| Measure |
Gout Storytelling Video
n=152 Participants
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
n=154 Participants
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Patient Satisfaction
|
62.16 units on a scale
Interval 57.09 to 67.23
|
67.43 units on a scale
Interval 62.39 to 72.47
|
SECONDARY outcome
Timeframe: 12 monthsSerum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes
Outcome measures
| Measure |
Gout Storytelling Video
n=152 Participants
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
n=154 Participants
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Target Serum Urate
|
5.94 mg/dL
Interval 5.61 to 6.27
|
5.72 mg/dL
Interval 5.41 to 6.04
|
Adverse Events
Gout Storytelling Video
Serious events: 0 serious events
Other events: 9 other events
Deaths: 4 deaths
Video About Management of Another Chronic Condition
Serious events: 0 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gout Storytelling Video
n=152 participants at risk
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
Video About Management of Another Chronic Condition
n=154 participants at risk
Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
Improvement of Medication Adherence: The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
|
|---|---|---|
|
Product Issues
Medication side effect on SATMED-Q side effect
|
5.9%
9/152 • Number of events 9 • 1-year
|
3.2%
5/154 • Number of events 5 • 1-year
|
Additional Information
Dr. Jasvinder Singh
VA ORD: Birmingham VA Medical Center
Phone: 205-934-3235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place