DDEP for Lifestyle Modification in Chronic Kidney Disease: A Randomized Feasibility Trial

Chronic Kidney Diseases Clinical Trial

Official title:

A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226649
• Other study ID #: NHRI-EX113-11106PI
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: National Cheng Kung University
• Contact: Miaofen Yen, PhD
• Phone: 886-6-2353535
• Email: miaofen[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other

Description:

The trial will be conducted on 60 dyads, each comprising a CKD patient and a significant other, who will be randomly assigned into two groups. The intervention group will receive the Digital Dyadic Empowerment Program (DDEP) while the control group will receive routine education and care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. The patient has a diagnosis of Chronic Kidney Disease for at least six months;

2. The patient can identify a helpful significant other and both parties are willing to participate;

3. The patient can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

1. The significant other is a healthcare provider;

2. The patient or the significant other has a mental illness diagnosis;

3. The patient is currently receiving renal replacement therapies.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Digital Dyadic Empowerment
The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include: Access to CKD Health Education Information; Supportive Information for Significant Others; Physiological Values Logging for Self-Monitoring; Reminders for Clinical Appointments and Daily Self-Management Tasks; Kidney Health Diary for Lifestyle Modification Progress Tracking; Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers. This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan City

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng Kung University	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL	Assessing perceived quality of life using the World Health Organization Quality of Life Questionnaire- brief (WHOQOL-BREF).	Before initial intervention and 3 months after initial intervention
Primary	Healthy Lifestyle (Patient-specific)	Assessing lifestyle using Health Promotion Lifestyle Profile-II: Chinese version short form (HPLP-II).	Before initial intervention and 3 months after initial intervention
Primary	Physiological data (Patient-specific)	clinical blood and urine test results (eGFR, HbA1C, Albumin, Hb, and Creatinine).	Before initial intervention and 3 months after initial intervention
Primary	Stage of Change	Assessing self-reported motivational status for lifestyle modification using the Trans-theoretical Model (TTM) Staging Inventory.	Before initial intervention and 3 months after initial intervention
Secondary	Relationship quality	Assessing perceived relationship quality using the Dyadic Adjustment Scale (DAS-7).	Before initial intervention and 3 months after initial intervention
Secondary	Adherence to Health Behaviors (Patient-specific)	Assessing adherence to health behaviors using Adherence to Health Behaviors (AHBS).	Before intervention and after intervention
Secondary	Helping relationship (Patient-specific)	Assessing helping relationship using Helping Relationship Significant Other: Chinese version short form (HRSO).	Before initial intervention and 3 months after initial intervention