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CompletedNCT04260100Updated Mar 11, 2021

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

An interventional study of Diabetes Care Self-Management Mobile Health Application in Diabetes Mellitus, Type 2, sponsored by Mohd Khairul Zul Hasymi Firdaus. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by Mohd Khairul Zul Hasymi Firdaus · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 68 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Mohd Khairul Zul Hasymi Firdaus is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Behavioral: Diabetes Care Self-Management Mobile Health Application

  • No intervention
    Control Group

    Routine care group

Interventions

  • BehavioralDiabetes 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.

06

What researchers measure

Primary outcomes

  1. Foot Care Behaviour

    The changes of foot care behaviour will be measured twice (Week 1 and Week 5) by using Diabetic Foot Selfcare Behaviour Scale (DFSBS). The questionnaire consist of two parts namely Part 1 and Part 2 with two set of different responses. In Part 1, there are four different questions measuring the self-care activity. The response for this Part 1 consists of days performed from 0 - 7 days. The response will be categorized based on Likert Scale according to the following categories; 0 days for score of 1, 1-2 days for score of 2, 3-4 days for score of 3, 5-6 days for score of 4 and 7 days for score of 5. In Part 2, the question responses are categorized as never (1), seldom (2), sometimes (3), frequently (4) and always (5). The total score accumulated will be in range of 7 - 35. The interpretation of the score will be the higher the score, the better the foot care behaviour.

    Time frame: 5 weeks; Baseline on Week 1 and follow up on Week 5

  2. Dietary Behaviour

    The changes of dietary behaviour will be measured twice (Week 1 and Week 5) by using translated Dietary Behavior Questionnaire (DBQ). The questionnaire consists of 30 items with four domains. The domains are selecting a healthy diet with 13 items; arranging a meal plan, 7 items; recognizing the amount of calorie needs, 5 items and managing dietary behaviour challenges, 5 items. 5 points of Likert scale is use from 0 to 4 with 0 for never, 1 for seldom, 2 for occasionally, 3 for often and 4 for repeatedly. The total score of DBQ is ranging from 0 to 120 with score of 0 to 40 categorized as poor behaviour, 41 to 80 categorized as medium and 81 to 120 categorized as better dietary behaviour.

    Time frame: 5 weeks; Baseline in Week 1 and follow up in Week 5

Secondary outcomes

  1. Foot Conditions

    The foot conditions will be assessed twice (Week 1 and Week 5) by using foot condition assessment form.

    Time frame: 5 weeks; baseline in Week 1 and post intervention in Week 5

  2. Fasting Blood Glucose

    The level of fasting blood glucose will be assessed twice (Week 1 and Week 5) by withdrawing participants blood for the test.The test will be sent to a certified laboratory for the analysis of FBG reading. Prior to blood taking procedure, the participants will be asked to fast.

    Time frame: 5 weeks; baseline in Week 1 and post intervention in Week 5

07

Study locations

1 site
  • Klinik Kesihatan UTC Kangar
    Kangar, Perlis Indera Kayangan 01000, Malaysia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04260100
Lead sponsor
Mohd Khairul Zul Hasymi Firdaus
Collaborators
Prince of Songkla University
Responsible party
Mohd Khairul Zul Hasymi Firdaus (Sponsor-Investigator, Prince of Songkla University) — Sponsor-investigator
First posted
Feb 7, 2020
Start date
Feb 17, 2020
Primary completion
Mar 3, 2020
Completion
Sep 15, 2020
Last update
Mar 11, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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