Trial Outcomes & Findings for Improving Diabetic Patient Health Through Assistive-Reading Technology (NCT NCT05337306)

For age: 30 GogyUp participants and 24 Control participants were missing baseline age. Age was not used as a covariate.

The first primary outcome is three-month (follow up) value of the Health Literacy Questionnaire (HLQ) subscale 9: Understanding health information well enough to know what to do The "Understanding health information" subscale is a multi-item, validated subscale of the HLQ and a continuous variable. It is a 5-item subscale, with items scored 1-5 (with higher scores being better) and then mean-aggregated. This study's main objective is to study the effect of GogyUp on health literacy (the ability to use and understand written health information) as a proximal effect of support. The Understanding health information subscale is the most direct measure; three-month follow up reflects (a) brief follow-up in a pilot trial; and (b) this outcome is very proximal to the intervention.

The other primary outcome measurement is the three-month (follow up) value of the validated Health Literacy Questionnaire Subscale 2: having sufficient information to manage my health. The "Having sufficient information" subscale is a multi-item, validated subscale of the HLQ and a continuous variable. It is a 4-item subscale, with items scored 1-4 (with higher scores being better) and then mean-aggregated. This study's main objective is to study the effect of GogyUp on health literacy (def: the ability to use and understand written health information) as a most proximal effect of in-the-moment support. As such, the Having sufficient information subscale is an additional direct measure; the three-month time frame reflects (a) a brief follow-up as part of a pilot trial; and (b) is reasonable because of the use of this proximal (to the intervention) outcome based on putative mechanisms.

The secondary outcome measure is the three month (follow-up) score on the Perceived Diabetes Self-Management Scale (PDSMS) PDSMS is a validated measure (continuous variable). It has eight items ranged 1-5 and summed (range 8-40), with higher scores being better. This study's objective is to study the effect of GogyUp on health literacy (the ability to use and understand written health information) as a proximal effect of in-the-moment support. However, any benefit is expected to be via translation of improved health literacy into improved diabetes self-management. As such, this secondary outcome is less proximal but still relevant. The three-month time frame reflects brief follow-up as part of a pilot trial but benefit may not accrue within the short timeframe, meaning this measure may be most useful for obtaining effect size estimates to inform sample size calculations for future studies.