Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease

Sponsor

National Cheng Kung University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06065501

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).

Condition or Disease	Intervention/Treatment	Phase
CKD - Chronic Kidney Disease	Behavioral: PACE intervention Behavioral: Usual care	N/A

Detailed Description

The study will be conducted on 120 frail patients with CKD, who will be divided into 2 groups: Group 1, consisting of 60 frail patients, will receive PACE intervention (based on mobile social network support) for 6 months. Group 2, comprising 60 frail patients, will receive usual CKD education and consultation for 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Frailty Trajectories and Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease: A Longitudinal Study

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PACE intervention The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.	Behavioral: PACE intervention "The PACE intervention involves using Line (technological devices) to establish a collaborative group with patients. The researchers will regularly provide reminders to chronic kidney disease patients regarding the importance of nutrition and exercise. They will also provide information on how to adhere to nutritional and exercise regimens, offering praise for consistent performance."
Active Comparator: Control group The control group receives usual care, which involves standard CKD education and consultation.	Behavioral: Usual care Nurses provide routine education and consultation

Arm

Intervention/Treatment

Experimental: PACE intervention

The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.

Behavioral: PACE intervention

"The PACE intervention involves using Line (technological devices) to establish a collaborative group with patients. The researchers will regularly provide reminders to chronic kidney disease patients regarding the importance of nutrition and exercise. They will also provide information on how to adhere to nutritional and exercise regimens, offering praise for consistent performance."

Active Comparator: Control group

The control group receives usual care, which involves standard CKD education and consultation.

Behavioral: Usual care

Nurses provide routine education and consultation

Outcome Measures

Primary Outcome Measures

Frailty [Before intervention, after initial intervention 3 months, and after intervention 6 months.]
Assessing frailty using the Tilburg Frailty Indicator.

Secondary Outcome Measures

Activity [Before intervention, after initial intervention 3 months, and after intervention 6 months.]
IPAQ-Taiwan
Lifestyle [Before intervention, after initial intervention and after intervention 6 months.]
Health-promoting lifestyle behaviors-Taiwan version
Nutrition [Before intervention, after initial intervention 3 months, and after intervention 6 months.]
Mini Nutritional Assessment Short-Form

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with CKD stage 1 to 5
Participants with pre-frail and frail conditions.
Having access to a mobile phone and is capable of using mobile social network application (Line)

Exclusion Criteria:

Received renal replacement therapy
Participants achieved TTM stage 5

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Cheng Kung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Miaofen Yen, Professor, Department of Nursing College of Medicine, National Cheng Kung University, National Cheng Kung University

ClinicalTrials.gov Identifier:

NCT06065501

Other Study ID Numbers:

B-ER-109-494

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 4, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Oct 4, 2023