Effectiveness of a Self-Management Support Integrated with the Mobile Health Application Program on Self-Management Behaviors, Blood Pressure, and Estimated Glomerular Filtration Rate among Persons with Chronic Kidney Disease Stage 3: A Randomized Controlled Trial

Phase 3

• Conditions: Chronic kidney disease stage 3; Self- management behaviors; Mobile health application

• Registration Number: TCTR20200928004
• Lead Sponsor: An Ethics Committee on Human Research, Research and Innovation Admisnistration Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-28
• Study Completion: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Patients aged 18-79 years and family member
2) CKD stage 3a (eGFR = 45-59 ml/min/1.73 m2) or 3b (eGFR = 30-44 ml/min/1.73 m2)
3) Co-morbidity diseases which controllable (using clinical parameters from medical history). For example, a person with hypertension must have blood pressure < 180/110 mmHg and without symptoms of hypertensive urgency or hypertensive crisis. A person with diabetes mellitus must have a blood sugar (FBS) level ≤ 250 mg/dl and without diabetic ketoacidosis etc.
4) Without cognitive impairment which screened by the Thai mental state examination (TMSE)
5) Having a mobile phone and ability in using mobile phone applications and internet access
6) Ability to read and write in Thai
7) Reside in Samut Prakan Province

Exclusion Criteria

1) The participants have advanced to stage 4 or 5 of CKD during the program.
2) The participants are having adjusted to increase the dose of the antihypertensive drug during the program.
Termination criteria:
1) The participants have a severe illness or are in a critical phase and must be hospitalized during the program.
2) The participants died during the program.
Withdrawal criteria:
1) The participants request to withdraw because they are inconvenient to participate in the research project as scheduled.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-Management Behaviors Baseline, post intervention at week 4, and follow up at week 12 The Self-Management Behaviors Questionnaire

Secondary Outcome Measures

Name	Time	Method
Blood Pressure and Estimated Glomerular Filtration Rate Baseline, post intervention at week 4, and follow up at week 12 The Clinical Outcomes Record Form