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

National Cheng Kung University

Status: Not yet enrolling

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: Digital Dyadic Empowerment

Study type: Interventional

Funder types: Other

Identifiers

NCT06226649

NHRI-EX113-11106PI

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Digital Dyadic Empowerment

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Dyadic Empowerment

Control group

No Intervention group

Description:

The control group receives routine education and care.