Mobile Health Application for Diabetes

NCT04132089 | Completed

• 1 other identifier: 1122
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

  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.

  9 Weeks

Study Arms (3)

Control

NO INTERVENTION

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.

Facilitator Message Group

OTHER

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

Spark Trigger Group

OTHER

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

Interventions

capABILITY BEHAVIORAL

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).

Facilitator Message Group; Spark Trigger Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Anyone with gestational diabetes

Sponsors & Collaborators

• University of South Alabama: lead

Related Publications (1)

• 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.

  PMID: 32175908 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

capa protein, Drosophila

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Scott Sittig, PhD

  University of South Alabama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A three factor cross-over design was utilized.

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 18, 2019
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share