Gout, Health Related Quality of Life, Low Medication Adherence
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 3, 6, 9, and 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gout Flares | 12 months | Participant-reported total number of gout flares in the last 1 month |
| Patient Satisfaction | 12 months | 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. |
| Target Serum Urate | 12 months | Serum 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
| Arm | Count |
|---|---|
| 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 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 5 |
| Overall Study | Lost to Follow-up | 17 | 8 |
| Overall Study | Moved out of State | 0 | 1 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Gout Storytelling Video | Total | Video About Management of Another Chronic Condition |
|---|---|---|---|
| Age, Continuous | 64 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 152 Participants | 306 Participants | 154 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 152 Participants | 306 Participants | 154 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 152 Participants | 306 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 152 | 5 / 154 |
| other Total, other adverse events | 9 / 152 | 5 / 154 |
| serious Total, serious adverse events | 0 / 152 | 0 / 154 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gout Storytelling Video | Medication Adherence | MEMSCap™ ULT MPR at 3-months | 72.61 percentage of days ULT was taken |
| Gout Storytelling Video | Medication Adherence | MEMSCap™ ULT MPR at 6-months | 68.52 percentage of days ULT was taken |
| Gout Storytelling Video | Medication Adherence | MEMSCap™ ULT MPR at 9-months | 65.85 percentage of days ULT was taken |
| Gout Storytelling Video | Medication Adherence | MEMSCap™ ULT MPR at 12-months | 60.54 percentage of days ULT was taken |
| Video About Management of Another Chronic Condition | Medication Adherence | MEMSCap™ ULT MPR at 12-months | 63.82 percentage of days ULT was taken |
| Video About Management of Another Chronic Condition | Medication Adherence | MEMSCap™ ULT MPR at 3-months | 70.12 percentage of days ULT was taken |
| Video About Management of Another Chronic Condition | Medication Adherence | MEMSCap™ ULT MPR at 9-months | 67.32 percentage of days ULT was taken |
| Video About Management of Another Chronic Condition | Medication Adherence | MEMSCap™ ULT MPR at 6-months | 69.33 percentage of days ULT was taken |
Gout Flares
Participant-reported total number of gout flares in the last 1 month
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gout Storytelling Video | Gout Flares | 0.74 Self-reported gout flares in 1 month |
| Video About Management of Another Chronic Condition | Gout Flares | 0.99 Self-reported gout flares in 1 month |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gout Storytelling Video | Patient Satisfaction | 62.16 units on a scale |
| Video About Management of Another Chronic Condition | Patient Satisfaction | 67.43 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gout Storytelling Video | Target Serum Urate | 5.94 mg/dL |
| Video About Management of Another Chronic Condition | Target Serum Urate | 5.72 mg/dL |