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NCT Number: NCT06065501

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

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

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Key information

Conditions

CKD - Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACE intervention

Behavioral

"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."

Usual Care

Behavioral

Nurses provide routine education and consultation

Primary outcomes

  1. Tilburg Frailty Indicator (TFI)

    Time frame: Baseline, 3 months, and 6 months post-intervention

    Frailty was measured using the Tilburg Frailty Indicator (TFI), a 15-item self-reported questionnaire assessing physical, psychological, and social domains. Total score ranges from 0 to 15, with higher scores indicating greater frailty.

Secondary outcomes

  1. Physical Activity Level Measured by IPAQ-Taiwan

    Time frame: Baseline, 3 months, and 6 months post-intervention

    Physical activity was assessed using the International Physical Activity Questionnaire - Taiwan version (IPAQ-Taiwan). Total physical activity score was calculated in MET-minutes/week, including walking, moderate, and vigorous intensity activities.

  2. Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)

    Time frame: Baseline, 3 months, and 6 months post-intervention

    Lifestyle behaviors were assessed using the HPLP-II, Taiwan version, including six subscales. Scores range from 52 to 208, with higher scores indicating more frequent health-promoting behaviors.

  3. Nutritional Status Measured by MNA-SF

    Time frame: Baseline, 3 months, and 6 months post-intervention

    Nutritional status was assessed using the Mini Nutritional Assessment - Short Form (MNA-SF), a 6-item tool scored 0-14. Higher scores indicate better nutritional status. A score ≥12 is considered normal. The Taiwan version was used.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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