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

NCT04260100 | Completed

• 1 other identifier: Diabetic Care Mobile App
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  5 weeks; Baseline on Week 1 and follow up on Week 5

• 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.

  5 weeks; Baseline in Week 1 and follow up in Week 5

Secondary Outcomes (2)

• Foot Conditions

  5 weeks; baseline in Week 1 and post intervention in Week 5

• Fasting Blood Glucose

  5 weeks; baseline in Week 1 and post intervention in Week 5

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Diabetes Care Self-Management Mobile Health Application

Control Group

NO INTERVENTION

Routine care group

Interventions

Diabetes Care Self-Management Mobile Health Application 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohd Khairul Zul Hasymi Firdaus: lead
• Prince of Songkla University: collaborator

Study Sites (1)

Klinik Kesihatan UTC Kangar

Kangar, Perlis Indera Kayangan, 01000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 37901368 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: February 17, 2020
• Primary Completion: March 3, 2020
• Study Completion: September 15, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

MY (1)