DDEP for Lifestyle Modification in Chronic Kidney Disease

NCT ID: NCT06226649

Last Updated: 2025-05-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-12-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Digital Dyadic Empowerment

The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.

Group Type EXPERIMENTAL

Digital Dyadic Empowerment

Intervention Type BEHAVIORAL

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:

1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. 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.

Control group

The control group receives routine education and care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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:

1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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LINE Official Account - Kidney Lifestyle

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Miaofen Yen

Professor, Department of Nursing, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miaofen Yen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

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National Cheng Kung University

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NHRI-EX113-11106PI

Identifier Type: -

Identifier Source: org_study_id

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