Mobile Health Application for Diabetes

Incorporating Behavioral Trigger Measures Into a Mobile Health (mHealth) App Design for Chronic Disease Management: Pilot Study in Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: capABILITY

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This was the control group for the messaging component of the study (push notifications). These participants only received the mobile health application called capABILITY without messages.
Other: Facilitator Message Group; This group of participants received the mobile health application called capABILITY and received three facilitator messages per week. Facilitator messages are designed to help people who lack ability to do something.	Behavioral: capABILITY; All participants utilized the designed capABILITy application. The application consisted of education material and persuasive messaging. There were two types of messaging components named facilitators and sparks. This created three groups consisting of: control, facilitators and sparks. Participants spent 1 month in each group (total duration of the study was three months).
Other: Spark Trigger Group; This group of participants received the mobile health application called capABILITY and received three spark messages per week. Spark messages are designed to help people who lack ability to do something.	Behavioral: capABILITY; All participants utilized the designed capABILITy application. The application consisted of education material and persuasive messaging. There were two types of messaging components named facilitators and sparks. This created three groups consisting of: control, facilitators and sparks. Participants spent 1 month in each group (total duration of the study was three months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.	Participants completed the Perceived Diabetes Self-Management Scale at baseline and post intervention to measure their self-efficacy. The measure (scale) consists of eight questions ranging from strongly disagree (1) to strongly agree (5). All items are scored so that high scores equals higher perceived self-efficacy.	9 Weeks
20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.	Participants completed the Brief Diabetes Knowledge Test (DKT2) at baseline and post intervention to measure their overall type II diabetes knowledge. The measure (scale) consists of twenty- three multiple choice knowledge questions. The score was calculated based on the number of questions answered correctly with higher scores representing a higher knowledge level.	9 Weeks
20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.	Participants completed the Summary of Diabetes Self-Care Activities Questionnaire at baseline and post intervention to measure their diabetes self-care. The measure (scale) consists of twenty five questions ranging from a score of 1 (days per week) to 7 (days per week). All items are scored so that high scores equals higher self-care.	9 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will engage quicker with capABILITY after they receive behavioral triggers (Sparks and Facilitators) than those participants who don't receive behavioral triggers. Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am. Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY. The smaller the number in seconds the quicker the login time from push notification delivery.	9 Weeks
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.	Participants will engage quicker with capABILITY after they receive Spark trigger messages than those who receive a Facilitator trigger message. Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am. Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY. The smaller the number in seconds the quicker the login time from push notification delivery.	9 Weeks

Collaborators and Investigators

• Sponsor: University of South Alabama
• Investigators: Principal Investigator: Scott Sittig, PhD, University of South Alabama

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1122 (Jian-jun Li)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participant data from this study will not be shared with other researchers. Findings of the study will be published however.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No