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Chronic Kidney DiseasesDDEPNCT06756113

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

A study testing Digital Dyadic Empowerment in people with Chronic Kidney Diseases, run by National Cheng Kung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Digital Dyadic Empowerment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteTaiwan
Study dates
13 Jan 2025to 15 Oct 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has a diagnosis of Chronic Kidney Disease for at least six months;
  • The patient can identify a helpful significant other, and both parties are willing to participate;
  • The patient can communicate in Mandarin or Taiwanese.

Who cannot join

  • The significant other is a healthcare provider;
  • The patient or the significant other has a mental illness diagnosis;
  • The patient is currently receiving renal replacement therapies;
  • Neither the patient nor the significant other uses a smartphone or the LINE messaging app.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University

    Tainan, 70101

Other trials in Taiwan

About this study

Official title: Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management: A Randomized Controlled Trial

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?
Read more

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.

Read the detailed 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.

Being tested
Digital Dyadic Empowerment, Usual Care
Keywords
digital health, dyadic empowerment, healthy lifestyle
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Dyadic EmpowermentBehavioural

    Also called LINE Official Account - Kidney Lifestyle

    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.

  • Usual CareBehavioural

    All patients in this study received regular nephrology care at National Cheng Kung University Hospital. Nephrologists conducted routine examinations and provided diagnoses based on test results. The patient's condition (e.g., changes in kidney function), treatment plan, prognosis, and risks were explained to both the patient and family members. The treatment plan included medication, monitoring blood pressure, dietary and exercise at home, and consultations with the Health Education Center for kidney care or nutrition advice.

Study groups in NCT06756113
Study groupRoleWhat they receive
Digital Dyadic Empowerment + Usual CareExperimentalThe 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.
Receives: Behavioral: Digital Dyadic Empowerment; Behavioral: Usual Care
Usual CareActive comparatorThe control group will receive usual care only.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in eGFR at 6 Months (Patient-specific)

    For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the Isotope Dilution Mass Spectrometry - Modification of Diet in Renal Disease (IDMS-MDRD) Equation at 6 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.

    Measured: Before initial intervention and 6 months after initial intervention

Secondary outcomes (4)

  1. Change From Baseline in CKD Stage at 6 Months (Patient-specific)

    For each patient, change from Baseline in CKD stage at 6 months was obtained by comparing the CKD stage at baseline and at follow-up, converted into the following three categories: (1) recover (e.g., from Stage 3a [at baseline] to Stage 2 [at follow-up]); (2) stable (e.g., remaining Stage 3a at both baseline and follow-up); and (3) progress (e.g., from Stage 3a [at baseline] to Stage 3b [at follow-up]).

    Measured: Before initial intervention and 6 months after initial intervention

  2. Change From Baseline in TTM Stage at 6 Months (Patient-specific)

    For each patient, change from Baseline in TTM stage at 6 months was obtained by comparing the TTM stage of change at baseline and at follow-up, converted into the following three categories: (1) regress (e.g., from Preparation [at baseline] to Contemplation [at follow-up]); (2) maintain (e.g., remaining Action at both baseline and follow-up); and (3) advance (e.g., from Action [at baseline] to Maintenance [at follow-up]).

    Measured: Before initial intervention and 6 months after initial intervention

  3. Change From Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific)

    For each patient, change from Baseline (Followup score - Baseline score) in patient's Health Promoting Lifestyle at 6 months was assessed using the Health Promoting Lifestyle Profile-II Chinese version Revised (HPLP-IICR), a validated scale with 30 items rated on a 4-point Likert scale. The total scores range from 30 to 120, with higher scores indicate better health-promoting lifestyle.

    Measured: Before initial intervention and 6 months after initial intervention

  4. Change From Baseline in Dyadic Adjustment at 6 Months

    For each participant, change from Baseline (Followup score - Baseline score) in Dyadic Adjustment at 6 months was assessed using the 7-item Dyadic Adjustment Scale (DAS-7). The first six items are rated on a 6-point scale, while the seventh item is rated on a 7-point scale. The total scores range from 0 to 36, with higher scores indicating better relationship quality.

    Measured: Before initial intervention and 6 months after initial intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start13 Jan 2025
  3. Primary completion8 Oct 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06756113
Sponsor's protocol ID
NHRI-EX114-11106PI
Acronym
DDEP
Status last verified
Jan 2026
First submitted
24 Dec 2024
Last updated
12 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital Dyadic Empowerment in people with Chronic Kidney Diseases, run by National Cheng Kung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in eGFR at 6 Months (Patient-specific) (time frame: Before initial intervention and 6 months after initial intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06756113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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