Mobile Health Application for Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132089
• Other study ID #: 1122
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: October 2019
• Source: University of South Alabama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Alabama

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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