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SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study

STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02741700
Acronym
STRIDE-GO2
Enrollment
306
Registered
2016-04-18
Start date
2017-05-31
Completion date
2021-08-31
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout, Health Related Quality of Life, Low Medication Adherence

Keywords

Adherence, Disparities, Patient Outcomes

Brief summary

The objective is to test the efficacy of a patient-centered, culturally relevant narrative intervention, or storytelling, based on the solid conceptual foundation of the narrative communication theory and the constructs of the Health Belief Model (HBM) to improve medication adherence and outcomes in chronic diseases among African-Americans (AA), using gout as an example. Gout is a chronic disease associated with chronic symptoms and disability interrupted by intermittent acute flares, similar to Chronic Obstructive Pulmonary Disease (COPD) and Congestive Heart Failure (CHF) that leads to joint destruction if not treated appropriately. Due to the intermittently symptomatic nature of chronic conditions, patients often don't perceive disease severity and susceptibility to disease complications, and, therefore, may not balance the barriers and benefits to medication adherence. Storytelling in the patients' own voices has the power to directly and more effectively confront a patient's barriers to medication adherence, reinforce the benefits and provide useful cues to action. Storytelling promotes patient engagement when the patient identifies with the storyteller and can lead to a patient's recognition of the need to treat the condition and improve health outcomes, as shown by a meaningful improvement in blood pressure in a recent clinical trial in AAs with hypertension. The success of this project, combined with other published data, will represent a major step toward demonstrating the effectiveness of storytelling to improve medication adherence in chronic diseases and will address two VA research priority areas, i.e., health care disparities and health care delivery.

Detailed description

The investigators will conduct a 12-month, multicenter, randomized controlled trial among 250 African-American Veterans with gout with a ULT medication possession ratio of \<80% at Birmingham, St. Louis, and Philadelphia VA clinics. The investigators will compare the efficacy of the storytelling intervention to usual care in improving Urate Lowering Therapy (ULT) adherence, assessed with MEMSCaps (electronic monitoring) at 6-months (primary outcome); reducing gout flares needing treatment, improving patient satisfaction, improving the ability to achieve target serum urate \<6 mg/dl and improving self-reported ULT adherence at 6-months (secondary outcomes). The investigators will assess these outcomes at 12-months as evidence for the sustenance of the effect of the intervention. Alignment with VA mission and priorities: This study serves the VA's mission of improving the health of Veterans and addresses two priority areas, 1) decreasing health care disparities and 2) improving health care delivery using a low-cost, technology-based solution to poor medication adherence. Study results will lead to a ready-to-implement low-cost patient-centered intervention for AA Veterans with gout to improve medication adherence and patient outcomes. This study will provide proof of the efficacy of storytelling for improving medication adherence in chronic symptomatic diseases. The storytelling intervention can be easily adapted for similar chronic symptomatic conditions such as COPD and CHF.

Interventions

BEHAVIORALGout Storytelling Video Intervention

The investigators developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management, which were narrated by several Veterans with gout. One of the veterans also presented a PowerPoint on gout and its management. The intervention was shown to the participants on a touchscreen computer or the desktop screen at the baseline study visit. Subsequently, they were provided with DVD with similar intervention to watch at home.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* African American Veteran Patients with Gout currently on urate-lowering therapy (ULT; most commonly allopurinol) with either low ULT adherence, defined as an average medication possession ration (MPR) \<0.80 or MPR \>=0.80

Exclusion criteria

* participants who use pill-box for ULT medication use * participants who Opt-out for the research will not be contacted

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence3, 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)

Secondary

MeasureTime frameDescription
Gout Flares12 monthsParticipant-reported total number of gout flares in the last 1 month
Patient Satisfaction12 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.
Target Serum Urate12 monthsSerum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
152
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.
154
Total306

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath45
Overall StudyLost to Follow-up178
Overall StudyMoved out of State01
Overall StudyPhysician Decision30
Overall StudyWithdrawal by Subject25

Baseline characteristics

CharacteristicGout Storytelling VideoTotalVideo About Management of Another Chronic Condition
Age, Continuous64 years
STANDARD_DEVIATION 8.3
64 years
STANDARD_DEVIATION 8.1
65 years
STANDARD_DEVIATION 8
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
152 Participants306 Participants154 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
152 Participants306 Participants154 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
152 Participants306 Participants154 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 1525 / 154
other
Total, other adverse events
9 / 1525 / 154
serious
Total, serious adverse events
0 / 1520 / 154

Outcome results

Primary

Medication Adherence

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)

Time frame: 3, 6, 9, and 12 months

ArmMeasureGroupValue (MEAN)
Gout Storytelling VideoMedication AdherenceMEMSCap™ ULT MPR at 3-months72.61 percentage of days ULT was taken
Gout Storytelling VideoMedication AdherenceMEMSCap™ ULT MPR at 6-months68.52 percentage of days ULT was taken
Gout Storytelling VideoMedication AdherenceMEMSCap™ ULT MPR at 9-months65.85 percentage of days ULT was taken
Gout Storytelling VideoMedication AdherenceMEMSCap™ ULT MPR at 12-months60.54 percentage of days ULT was taken
Video About Management of Another Chronic ConditionMedication AdherenceMEMSCap™ ULT MPR at 12-months63.82 percentage of days ULT was taken
Video About Management of Another Chronic ConditionMedication AdherenceMEMSCap™ ULT MPR at 3-months70.12 percentage of days ULT was taken
Video About Management of Another Chronic ConditionMedication AdherenceMEMSCap™ ULT MPR at 9-months67.32 percentage of days ULT was taken
Video About Management of Another Chronic ConditionMedication AdherenceMEMSCap™ ULT MPR at 6-months69.33 percentage of days ULT was taken
Secondary

Gout Flares

Participant-reported total number of gout flares in the last 1 month

Time frame: 12 months

ArmMeasureValue (MEAN)
Gout Storytelling VideoGout Flares0.74 Self-reported gout flares in 1 month
Video About Management of Another Chronic ConditionGout Flares0.99 Self-reported gout flares in 1 month
Secondary

Patient Satisfaction

Patient 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.

Time frame: 12 months

ArmMeasureValue (MEAN)
Gout Storytelling VideoPatient Satisfaction62.16 units on a scale
Video About Management of Another Chronic ConditionPatient Satisfaction67.43 units on a scale
Secondary

Target Serum Urate

Serum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes

Time frame: 12 months

ArmMeasureValue (MEAN)
Gout Storytelling VideoTarget Serum Urate5.94 mg/dL
Video About Management of Another Chronic ConditionTarget Serum Urate5.72 mg/dL

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026