Clinical trial NCT04132089: Mobile Health Application for Diabetes
Official title: Incorporating Behavioral Trigger Measures Into a Mobile Health (mHealth) App Design for Chronic Disease Management: Pilot Study in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A three factor cross-over design was utilized.
Primary purpose: OTHER

Brief summary: Creation of a mobile health application for individuals with type II diabetes. This application was designed to improve knowledge, self-efficacy and self-care. The application delivered educational material and provided push notifications (messages). It also allowed for the participants to key in blood glucose levels, carbohydrate consumption and daily exercise.

Detailed description: capABILITY (the mobile health application) was designed to cover three main diabetes content areas which the investigators call modules: diet (module 1), exercise (module 2) and self-management (module 3) (i.e. medication adherence, glucose monitoring). The length of the study was 9 weeks in duration with three weeks of content per module. Within each module new material was delivered each week through capABILITY. Essentially, every Monday started a new week's worth of educational material that was intended to last until Sunday. Each participant was randomly assigned to either the control group (no triggers), spark trigger group or facilitator trigger group. At the beginning of each module the participants would be randomly assigned to one of the three aforementioned classification groups (this was a 2-Factor Cross-Over Design).

The investigators utilized the Perceived Diabetes Self-Efficacy Scale , Diabetes Knowledge Test developed by Michigan University, and the Summary of Diabetes Self-Care Activities Measures scale (SDSCA) . All the participants completed the perceived diabetes self-efficacy scale along with the knowledge test and SDSCA Pre/Post intervention. In addition, the participants answered one self-efficacy, knowledge, self-care and goal question at the conclusion of each week within capABILITY.

Eligibility criteria: Inclusion Criteria:

* Must be at least 21 years of age or older
* Current diagnosis of type II diabetes
* Must have access to a smartphone and daily internet (WiFi)

Exclusion Criteria:

* Anyone with gestational diabetes

Primary outcomes:
measure: 20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
timeFrame: 9 Weeks
measure: 20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
timeFrame: 9 Weeks
measure: 20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
timeFrame: 9 Weeks
Secondary outcomes:
measure: Participants will login and use capABILITY quicker (time measured in seconds) after receiving a behavioral trigger message than those participants who don't receive a behavioral trigger.
timeFrame: 9 Weeks
measure: Participants who receive a Spark trigger message will login and use capABILITY quicker (time measured in seconds) than those participants who receive Facilitator trigger message.
timeFrame: 9 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of South Alabama
name: Scott Sittig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sittig S, Wang J, Iyengar S, Myneni S, Franklin A. Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes. JMIR Mhealth Uhealth. 2020 Mar 16;8(3):e15927. doi: 10.2196/15927.