Patient-Centered Outcomes and Key Study Procedure Finalization in the Pilot Feasibility Gout Randomized Trial: Comparative Feasibility Study in GOUt, CHerry Extract Versus Diet Modification (Mini-GOUCH).

Abstract

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.

• Authors: Jasvinder A Singh, Amanda L Willig, Betty Darnell, Candace Green, Sarah Morgan, Rick Weiss, Kenneth G Saag, Gary Cutter, Gerald McGwin
• Journal: Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases (J Clin Rheumatol) Vol. 26 Issue 5 Pg. 181-191 (Aug 2020) ISSN: 1536-7355 [Electronic] United States
• PMID: 30870252 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Plant Extracts

Topics

• Feasibility Studies
• Gout (diagnosis, therapy)
• Humans
• Patient-Centered Care
• Plant Extracts (therapeutic use)
• Symptom Flare Up