Chronic Kidney DiseasesNCT06226649

DDEP for Lifestyle Modification in Chronic Kidney Disease

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

This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other 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
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteTaiwan
Study dates: 29 Jan 2024to 2 Dec 2024
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.

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

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

Read the detailed 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.

Conditions: Chronic Kidney Diseases
Being tested: Digital Dyadic Empowerment
Keywords: feasibility studies, digital health, 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.

Study groups in NCT06226649
Study group	Role	What they receive
Digital Dyadic Empowerment	Experimental	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. Receives: Behavioral: Digital Dyadic Empowerment
Control group	No intervention	The control group receives routine education and care.

What is being measured

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

Change From Baseline in eGFR at 3 Months (Patient-specific)
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation at 3 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
Measured: Before initial intervention and 3 months after initial intervention
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
For each patient, the change from Baseline in CKD stage at 3 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 3 months after initial intervention
Change From Baseline in TTM Stage at 3 Months
For each dyad, change from Baseline in TTM stage at 3 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 Maintanece [at follow-up]).
Measured: Before initial intervention and 3 months after initial intervention
Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
For each patient, change from Baseline (Followup score - Baseline score) in patient's Health Promoting Lifestyle at 3 months was assessed using the Chinese version of the Health Promoting Lifestyle Profile-II (HPLP-II), a validated scale with 52 items rated on a 4-point Likert scale. The total scores range from 52 to 208, with higher scores indicate better health-promoting behavior.
Measured: Before initial intervention and 3 months after initial intervention
Change From Baseline in Quality of Life at 3 Months
For each participant, change from Baseline (Followup score - Baseline score) in Quality of Life at 3 months was assessed using the first item of the Taiwanese version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The item was rated on a 5-point Likert scale, ranging from 1 to 5. Higher scores indicate better quality of life.
Measured: Before initial intervention and 3 months after initial intervention

Secondary outcomes (3)

Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)
For each patient, change from Baseline (Followup score - Baseline score) in patient's adherence to healthy behaviors was measured using the Adherence to Healthy Behaviors Scale (AHBS). The scale includes 13 items rated on a 5-point Likert scale, with total scores ranging from 0 to 52. Higher scores indicate better adherence.
Measured: Before initial intervention and 3 months after initial intervention
Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)
For each patient, change from Baseline (Followup score - Baseline score) in patient's Helping Relationships from Significant Others at 3 months was assessed using the Chinese version of the Helping Relationships from Significant Others Scale (HRSO).The scale consists of 15 items rated on a 7-point Likert scale, with total scores ranging from 15 to 105. Higher scores indicate better support from the significant other.
Measured: Before initial intervention and 3 months after initial intervention
Change From Baseline in Dyadic Adjustment at 3 Months
For each participant, change from Baseline (Followup score - Baseline score) in Dyadic Adjustment at 3 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 3 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.

29 Jan 20242 Dec 2024

First posted26 Jan 2024
Study start29 Jan 2024
Primary completion8 Nov 2024
Study completion2 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06226649
Sponsor's protocol ID: NHRI-EX113-11106PI
Status last verified: Apr 2025
First submitted: 18 Jan 2024
Last updated: 2 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ho CY, Siregar D, Lin WH, Sung JM, Wang MC, Yen M. Dyadic mobile intervention empowering lifestyle modification in chronic kidney disease management: A feasibility randomized controlled trial. Int J Nurs Stud Adv. 2026 May 14;10:100549. doi: 10.1016/j.ijnsa.2026.100549. eCollection 2026 Jun.
PubMed 42205542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management
ClinicalTrials.gov ID: NCT06226649
Acronym / sponsor ID: NHRI-EX113-11106PI
Conditions: Chronic Kidney Diseases
Keywords: feasibility studies, digital health, healthy lifestyle
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: National Cheng Kung UniversityUniversity, hospital or other
Collaborators: National Health Research Institutes, Taiwan
Study start: 29 Jan 2024 (actual)
Primary completion: 8 Nov 2024 (actual)
Study completion: 2 Dec 2024 (actual)
First posted: 26 Jan 2024 (actual)
Results: Posted 9 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Digital Dyadic Empowerment	Experimental	Behavioral: Digital Dyadic EmpowermentThe 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.
Control group	No intervention	–The control group receives routine education and care.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digital Dyadic EmpowermentAlso: LINE Official Account - Kidney LifestyleThe 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.	Behavioural	Digital Dyadic Empowerment

Primary outcome

Change From Baseline in eGFR at 3 Months (Patient-specific)
Time frame: Before initial intervention and 3 months after initial intervention
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation at 3 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
Time frame: Before initial intervention and 3 months after initial intervention
For each patient, the change from Baseline in CKD stage at 3 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]).
Change From Baseline in TTM Stage at 3 Months
Time frame: Before initial intervention and 3 months after initial intervention
For each dyad, change from Baseline in TTM stage at 3 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 Maintanece [at follow-up]).
Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
Time frame: Before initial intervention and 3 months after initial intervention
For each patient, change from Baseline (Followup score - Baseline score) in patient's Health Promoting Lifestyle at 3 months was assessed using the Chinese version of the Health Promoting Lifestyle Profile-II (HPLP-II), a validated scale with 52 items rated on a 4-point Likert scale. The total scores range from 52 to 208, with higher scores indicate better health-promoting behavior.
Change From Baseline in Quality of Life at 3 Months
Time frame: Before initial intervention and 3 months after initial intervention
For each participant, change from Baseline (Followup score - Baseline score) in Quality of Life at 3 months was assessed using the first item of the Taiwanese version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The item was rated on a 5-point Likert scale, ranging from 1 to 5. Higher scores indicate better quality of life.

3 secondary outcomes

Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)
Time frame: Before initial intervention and 3 months after initial intervention
Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)
Time frame: Before initial intervention and 3 months after initial intervention
Change From Baseline in Dyadic Adjustment at 3 Months
Time frame: Before initial intervention and 3 months after initial intervention

Results and safety

Results posted to the registry on 9 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Digital Dyadic Empowerment	30	26
Control Group	30	29

Primary outcome: Change From Baseline in eGFR at 3 Months (Patient-specific)

Time frame: Before initial intervention and 3 months after initial intervention. Mean (95% Confidence Interval). Unit: ml/min/1.73m^2

Measure	Digital Dyadic Empowerment n = 26	Control Group n = 29
Value	-1.71 (-3.58 to 0.17)	-4.12 (-9.11 to 0.86)

Population analysed: The test of eGFR was conducted only on patient participants.

Primary outcome: Change From Baseline in CKD Stage at 3 Months (Patient-specific)

Time frame: Before initial intervention and 3 months after initial intervention. Count of participants. Unit: Participants

Measure	Digital Dyadic Empowerment n = 26	Control Group n = 29
Recover	2	4
Stable	18	20
Progress	6	5

Population analysed: This measure was conducted only on the patient participants.

Primary outcome: Change From Baseline in TTM Stage at 3 Months

Time frame: Before initial intervention and 3 months after initial intervention. Number. Unit: dyad

Measure	Digital Dyadic Empowerment n = 51	Control Group n = 58
Regress	4	5
Maintain	14	19
Advance	8	5

Population analysed: This measure was reported jointly by the patient and the significant other within each dyad.

Primary outcome: Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)

Time frame: Before initial intervention and 3 months after initial intervention. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Digital Dyadic Empowerment n = 26	Control Group n = 29
Value	5.96 (-0.77 to 12.70)	-8.17 (-18.52 to 2.18)

Population analysed: This questionnaire was only administrated to the patient participants.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digital Dyadic Empowerment	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Control Group	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): Since this is a feasibility trial, the change from baseline estimates for all outcomes were underpowered, and therefore 95% confidence intervals (CIs) were reported instead.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42205542Ho CY, Siregar D, Lin WH, Sung JM, Wang MC, Yen M. Dyadic mobile intervention empowering lifestyle modification in chronic kidney disease management: A feasibility randomized controlled trial. Int J Nurs Stud Adv. 2026 May 14;10:100549. doi: 10.1016/j.ijnsa.2026.100549. eCollection 2026 Jun.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Diseases

Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miaofen Yen, PhD principal investigator

National Cheng Kung University

1 site in 1 country: see every site and its status.

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 3 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 2 May 2025. 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 9 Apr 2025). 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 3 Months (Patient-specific) (time frame: Before initial intervention and 3 months after initial intervention). The study lists 5 primary outcomes in all. 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 NCT06226649, which also lists 1 linked publication.

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 2 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.