JMIR Publications

ABSTRACT

Background:

In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥ 65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease process or intervention effect. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of a patient’s health.

Objective:

This study examines the feasibility of collecting Patient Reported Outcome Measurements Information System (PROMIS) measures and preliminarily evaluates changes in PROMIS scores and makes a comparison with standard scores of the general US population. The parent study is a pilot randomized controlled trial testing 3 different modes (mobile health, paper-diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight/obese patients with T2D.

Methods:

Patients with comorbid overweight/obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to three groups: mobile health (mHealth), paper-diary, and control (standard of care) groups. Paper-diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes 7 domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of 2 domains: global mental health (GMH) and global physical health (GPH).

Results:

A total of 26 patients (mHealth =11, paper-diary = 9, control = 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%) with an average age of 54.7 years and a body mass index of 37.5. All patients completed PROMIS-57 and the PROMIS-GH, we compared the mean scores of the three groups to investigate potential differences. No statistical differences were noted across groups (p > .05). However, positive trends were noted in both intervention (mHealth and paper-diary) groups in the middle (3rd month) and end of the study (6th month).

Conclusions:

Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D related symptoms among overweight/obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention.