Clinical trial NCT04260100: Diabetic Care Self-Management Mobile Health Application Among Diabetes Mellitus Clients in Malaysia
Official title: The Effects of Diabetic Care Self-Management Mobile Health Application on Foot Care Behaviour, Dietary Behaviour, Foot Conditions and Fasting Blood Glucose Among Diabetes Mellitus Clients in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
Collaborators: name: Prince of Songkla University
First posted: 2020-02-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Foot Care Behaviour
timeFrame: 5 weeks; Baseline on Week 1 and follow up on Week 5
measure: Dietary Behaviour
timeFrame: 5 weeks; Baseline in Week 1 and follow up in Week 5
Secondary outcomes:
measure: Foot Conditions
timeFrame: 5 weeks; baseline in Week 1 and post intervention in Week 5
measure: Fasting Blood Glucose
timeFrame: 5 weeks; baseline in Week 1 and post intervention in Week 5
Other outcomes:
Locations:
city: Kangar
country: Malaysia
facility: Klinik Kesihatan UTC Kangar
state: Perlis Indera Kayangan
Study officials:
References: