Digital Dyadic Empowerment Program on Lifestyle Modification for Chronic Kidney Disease Management (DDEP)

National Cheng Kung University

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: Usual Care; Behavioral: Digital Dyadic Empowerment

Study type: Interventional

Funder types: Other

Identifiers

NCT06756113

NHRI-EX114-11106PI

Details and patient eligibility

About

The goal of this clinical trial is to find out if the Digital Dyadic Empowerment Program (DDEP) can help people with chronic kidney disease (CKD) and their care partners make healthy lifestyle changes. The main questions this study will answer are:

• Does DDEP help protect kidney function?
• Does DDEP support healthier daily habits?

Researchers will compare two groups:

• One group will receive the DDEP and get usual medical care.
• The other group will get usual medical care only.

Participants will:

• Receive usual care with or without DDEP for six months.
• Visit the clinic at the start and end of the study for health checks and tests.
• Practice healthy habits at home with or without help from DDEP.

This study aims to show if adding DDEP to regular care can make it easier for people with CKD and their care partners to live healthier lives.

Full description

This randomized controlled trial (RCT) aims to evaluate the long-term effects of the Digital Dyadic Empowerment Program (DDEP) in comparison to routine care for people with chronic kidney disease (CKD) and their significant others. The study will assess whether the DDEP can improve health outcomes such as kidney function, health-promoting lifestyle behaviors, and the quality of relationships between significant others over a six-month period. The trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 and CONSORT-EHEALTH guidelines to ensure rigorous reporting and transparency.

Baseline assessments will occur in a private clinic room and will include demographic information, disease-related characteristics, and self-reported measures. Participants in both groups will also complete the Trans-Theoretical Model (TTM) staging inventory to evaluate their readiness for lifestyle changes. Dyads assigned to the intervention group will receive DDEP setup instructions and training on platform use during the baseline visit. Throughout the study, dyads will be encouraged to utilize the platform for self-management tasks at home, including diet tracking, exercise planning, and monitoring blood pressure.

Enrollment: 208 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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;
4. Neither the patient nor the significant other uses a smartphone or the LINE messaging app.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups

Digital Dyadic Empowerment + Usual Care

Experimental group

Description:

The intervention group (Digital Dyadic Empowerment + Usual Care) will receive usual care and utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification at home along with support from the significant other.

Treatment:

Behavioral: Digital Dyadic Empowerment

Behavioral: Usual Care

Usual Care

Active Comparator group

Description:

The control group will receive usual care only.

Treatment:

Behavioral: Usual Care