Improving Health Literacy on Chronic Kidney Disease Among Diabetics: the Malaysian Nutritional, Emotional and Physical Health Literacy for Optimal Renal Outcome (My-NEPHRO) Trial

NCT07836556 | Not Yet Recruiting DMC

• 1 other identifier: UniSZA/2023/KTP/04
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a health literacy module via mobile application intervention can improve health outcomes and health literacy in diabetics with chronic kidney disease and could include any of the following: diabetic patients with non-dialysis chronic kidney disease aged more than 18 years old. The main questions it aims to answer are:

1. 1.Are there differences in health literacy between intervention and control group at pre- and post-3 and 6 month exposure to the health literacy module in both intervention and control groups
2. 2.Are there differences in quality of life scores between intervention and control group at pre- and post-3 and 6 month exposure to the health literacy module in both intervention and control groups?
3. 3.Are there differences in renal function(eGFR) and HbA1C in pre- and post- 6 month exposure to the health literacy module between the intervention and control groups? Researchers will compare with normal care to see whether the effect of this intervention is larger than the effect of usual care in improving health literacy and HbA1c level, and impact towards renal disease progression and quality of life in diabetics with chronic kidney disease.

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Health Literacy; Quality of Life

Keywords

diabetes mellitus; renal insufficiency, chronic; quality of life; health literacy

Outcome Measures

Primary Outcomes (1)

• health literacy score

  Score of health literacy

  From enrolment, at 3 months and at the end of intervention at 6 months

Secondary Outcomes (3)

• HbA1C

  From enrolment to end of intervention at 6 months

• Renal function

  From enrolment to end of intervention at 6 months

• Quality of life score

  From enrolment, at 3 months and at the end of intervention at 6 months

Study Arms (2)

Normal care

NO INTERVENTION

Normal follow-up with health care provider

Mobile application

EXPERIMENTAL

A health literacy intervention module via mobile application

Other: Mobile application

Interventions

Mobile application OTHER

A health literacy intervention module via mobile application

Also known as: MyNEPHRO

Mobile application

Eligibility Criteria

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

You may qualify if:

• (1) are more than 18 years old who live, work, or study in Kuala Terengganu, Terengganu, Malaysia 2) are diabetics with CKD (Stages I- IV) as diagnosed by their physicians (3) own a smartphone (only Android) (4) are fluent in the Malay language; and (5) are willing to participate in programme.

You may not qualify if:

• those having comorbid conditions affecting the kidney such as nephrolithiasis
• those participating in additional health education programmes or interventional research
• those who are already using a mobile application for self-management.
• Those who had been admitted for any renal problems for the past one month.

Sponsors & Collaborators

• Universiti Sultan Zainal Abidin: lead
• Ministry of Higher Education, Malaysia: collaborator

Related Publications (3)

• Deshpande N, Wu M, Kelly C, Woodrick N, Werner DA, Volerman A, Press VG. Video-Based Educational Interventions for Patients With Chronic Illnesses: Systematic Review. J Med Internet Res. 2023 Jul 19;25:e41092. doi: 10.2196/41092.

  PMID: 37467015 BACKGROUND

• Billany RE, Thopte A, Adenwalla SF, March DS, Burton JO, Graham-Brown MPM. Associations of health literacy with self-management behaviours and health outcomes in chronic kidney disease: a systematic review. J Nephrol. 2023 Jun;36(5):1267-1281. doi: 10.1007/s40620-022-01537-0. Epub 2023 Jan 16.

  PMID: 36645651 BACKGROUND

• Alexandre NM, Coluci MZ. [Content validity in the development and adaptation processes of measurement instruments]. Cien Saude Colet. 2011 Jul;16(7):3061-8. doi: 10.1590/s1413-81232011000800006. Portuguese.

  PMID: 21808894 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

NURULHUDA BINTI MAT HASSAN, MBBS

CONTACT

800-555-5555; nurulhudamh@unisza.edu.my

Sharifah Wafa

CONTACT

800-555-5555; sharifahwajihah@unisza.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A health literacy intervention module via mobile application

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-08