Diabetic Care Self-Management Mobile Health Application Among Diabetes Mellitus Clients in Malaysia

NCT ID: NCT04260100

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2020-09-15

Brief Summary

The main purpose of this study is to explore the effect of Diabetic Care Self-Management Mobile Health Application in behavioral modification i.e foot care behaviour and dietary behaviour among diabetic clients in Malaysia. Diabetic Care Self-Management Mobile Health Application is a mobile health (mHealth) application program aiming for primary care in health prevention and promotion activity. The program is developed by the researcher through the literature review conducted. The program is evaluated through a randomized controlled trial study design.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Group Type: EXPERIMENTAL

Diabetes Care Self-Management Mobile Health Application

Intervention Type: BEHAVIORAL

In day 1, the participant will receive a Foot Care Kit consist of a mirror, a tube of lotion, a small towel, and a nail clipper. The participant will enrol in 3-hour workshop for general management of diabetes mellitus, diabetic foot care and dietary management. The participant will be invited to install Diabetes Care Self-Management Mobile Health Application. The mobile application is meant for sources of referral for diabetic foot care and dietary care, and for record purpose (diary) of any foot care activities carried out that participant needs to enter in the application during his/her home. The participant will be trained for the use of Diabetes Care Mobile Health Application. In addition, the participant will be invited to join a WhatsApp group for the medium of communication. The program will be lasting for 5 weeks.

Control Group

Routine care group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diabetes Care Self-Management Mobile Health Application

In day 1, the participant will receive a Foot Care Kit consist of a mirror, a tube of lotion, a small towel, and a nail clipper. The participant will enrol in 3-hour workshop for general management of diabetes mellitus, diabetic foot care and dietary management. The participant will be invited to install Diabetes Care Self-Management Mobile Health Application. The mobile application is meant for sources of referral for diabetic foot care and dietary care, and for record purpose (diary) of any foot care activities carried out that participant needs to enter in the application during his/her home. The participant will be trained for the use of Diabetes Care Mobile Health Application. In addition, the participant will be invited to join a WhatsApp group for the medium of communication. The program will be lasting for 5 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Past readings of A1c more than 6.5% (Ministry of Health Malaysia, 2015).
• Has at least Stage 1 or above for the risk of foot ulcer development. The risk will be identified through diabetic foot screening. The screening will be carried out by using Inlow's 60 Second Diabetic Foot Screen.
• Age of 18 to 65 years old. Since the study is using mobile health applications, technology literate is an important factor to see the effect of mHealth on behaviour modification process. If the patient is more than 65 years old, the patient might have some difficulties in using mobile health intervention. Meanwhile, for the patient less than 18 years old, guardian permission is required prior to study enrolment.
• Have no history of diabetic foot ulcers.
• Able to independently perform self-care.
• Able to use a mobile application program.
• Own an android phone.
• No vision or hearing problem may interfere with the process of data collection and intervention carried out.
• Able to communicate in either English or Bahasa Malaysia (a native and official language of the country)

Exclusion Criteria

• The patient that did not come for the follow-up care at Week 5. For instance, the patient may have other matters on the day of follow-up up which required their urgent attention and not able to come for the follow-up, or is stay outside of the area during the day of follow up.
• Have difficulty in performing foot care during in the middle of the intervention period. For example, the client may get sick due to hypoglycemic or hyperglycemic attack which stopped them from being able to perform the foot care behaviour.
• The patient is diagnosed with any cognitive and perceptual decline function

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: collaborator

Mohd Khairul Zul Hasymi Firdaus

OTHER

Sponsor Role: lead

Responsible Party

Mohd Khairul Zul Hasymi Firdaus

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Klinik Kesihatan UTC Kangar

Kangar, Perlis Indera Kayangan, Malaysia

Countries

Malaysia

References

Firdaus MKZH, Jittanoon P, Boonyasopun U, Che Hasan MK. The effect of mHealth program on behavior modification and health outcomes among patients with diabetes: A randomized controlled trial study. Belitung Nurs J. 2023 Oct 26;9(5):437-447. doi: 10.33546/bnj.2664. eCollection 2023.

Reference Type: DERIVED

PMID: 37901368 (View on PubMed)

Other Identifiers

Diabetic Care Mobile App

Identifier Type: -

Identifier Source: org_study_id