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Patient-Centered Outcomes and Key Study Procedure Finalization in the Pilot Feasibility Gout Randomized Trial:
Jasvinder A Singh, Amanda L Willig1, Betty Darnell2
1Division of Infectious Diseases, Department of Medicine at School of Medicine.
Insights
This pilot study found that online gout interventions using cherry extract or diet modification were well-accepted by patients. Key procedures were finalized, paving the way for future internet-based gout trials.
Area of Science:
- Rheumatology
- Digital Health
- Nutritional Science
Background:
- Gout management often involves lifestyle modifications, but adherence can be challenging.
- Internet-based interventions offer a scalable approach to patient education and management.
- Pilot studies are crucial for assessing the feasibility and acceptability of novel digital health interventions.
Purpose of the Study:
- To evaluate patient-centered outcomes and finalize study procedures for a 9-month pilot internet randomized controlled trial.
- To compare cherry extract supplementation with dietitian-assisted diet modification for gout management.
- To assess the acceptability, feasibility, and participant satisfaction with an internet-based intervention platform.
Main Methods:
- 84 individuals with confirmed gout were randomized to receive either cherry extract (n=41) or dietitian-assisted diet modification (n=43) via an internet platform.
- Study outcomes, including dietary intake and Health Assessment Questionnaire (HAQ) scores, were collected remotely via the internet and phone calls.
- Key study procedures, such as gout flare assessment and serum urate testing, were finalized for future large-scale trials.
Main Results:
- Participant satisfaction with both interventions and the study website was very high, with perceived ease of use and helpfulness.
- The diet modification group showed significantly lower calorie, carbohydrate, and saturated fat intake at 6 months, but differences diminished by 9 months.
- Cherry extract led to significant improvements in more Health Assessment Questionnaire domains (6/8) compared to diet modification (2/8) from baseline to 9 months.
Conclusions:
- The high patient acceptability and feasibility of the internet-based interventions and finalized study procedures support the potential for future hypothesis-testing online trials.
- Internet-based interventions involving cherry extract and/or diet modification are viable for future gout research.
- This pilot study successfully established robust procedures for conducting large-scale internet randomized controlled trials in gout patients.
Objective:
The aim of this study was to report patient-centered outcomes and finalization of key study procedures from a 9-month pilot internet randomized controlled trial of cherry extract versus diet modification.
Methods:
We randomized 84 people with physician-confirmed gout in an internet study to cherry extract (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via internet and phone calls. We finalized key study procedures. We assessed acceptability and feasibility of the intervention and satisfaction with study website.
Results:
Study participant satisfaction with the intervention was high. The intervention was perceived as easy, enjoyable, understandable, and helpful (scores 65-88 for all; higher = better). The amount of time spent for the study was acceptable. Participant satisfaction with website interaction and content was very high; 85% or more were moderately to extremely satisfied. Significantly lower total calories, total carbohydrate, and saturated fat intake were noted at 6 months in the diet modification versus cherry extract group; differences were insignificant at 9 months. Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group. Key study procedures were finalized for a future trial, including an internet diet assessment tool, gout flare assessment, provider confirmation of gout diagnosis, patient reporting of classification criteria, and centralized laboratory-assisted serum urate testing.
Conclusions:
High patient acceptability and feasibility of study/intervention and finalization of key study procedures indicate that hypothesis-testing internet gout trials of cherry extract and/or diet modification can be conducted in the future.
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