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This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACE intervention | Experimental | 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. |
|
| Control group | Active Comparator | The control group receives usual care, which involves standard CKD education and consultation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Tilburg Frailty Indicator (TFI) | 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. | Baseline, 3 months, and 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Level Measured by IPAQ-Taiwan | 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. | Baseline, 3 months, and 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Taiwan |
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A total of 120 participants were enrolled and assigned to study arms.
Patients with CKD were recruited from outpatient clinics in hospitals located in southern Taiwan. The eligibility criteria included: (i) age 20 years or older; (ii) diagnosis of CKD stage 1 to 5 for at least 6 months; (iii) identified as frail; (iv) the ability to communicate in Mandarin Chinese or Taiwanese; and (v) willingness to participate in the study. The exclusion criteria were: (i) receiving renal replacement therapy, (ii) a history of mental illness, and (iii) having reached TTM stage 5
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | The control group receives usual care, which involves standard CKD education and consultation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at the time of enrollment, based on medical record documentation. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tilburg Frailty Indicator (TFI) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months post-intervention |
|
From baseline to the final follow-up at 6 months post-intervention.
Adverse event data were collected systematically at baseline, 3 months, and 6 months via participant interviews. Definitions aligned with ClinicalTrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death, cause unknown | General disorders | Systematic Assessment | The participant was found deceased during the intervention period. No specific cause was determined after clinical evaluation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| No other adverse events reported | General disorders | Systematic Assessment | No non-serious adverse events were observed or reported during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Miaofen Yen / Professor of Nursing department | National Cheng Kung University | 886-6-2353535 | 5823 | miaofen@mail.ncku.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2025 | May 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Usual care | Behavioral | Nurses provide routine education and consultation |
|
| Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 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. | Baseline, 3 months, and 6 months post-intervention |
| Nutritional Status Measured by MNA-SF | 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. | Baseline, 3 months, and 6 months post-intervention |
The control group receives usual care, which involves standard CKD education and consultation. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Sex assigned based on patient-reported information at enrollment. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Education Level | Highest education level attained by participant. | Count of Participants | Participants |
|
| Marital Status | Marital status at baseline (e.g., married, single, widowed). | Count of Participants | Participants |
|
| Living Status | Whether participants lived alone or with others. | Count of Participants | Participants |
|
| Estimated Glomerular Filtration Rate (eGFR) | Calculated using MDRD formula. | Mean | Standard Deviation | mL/min/1.73m² |
|
| Serum Albumin | Measured at baseline via blood test. | Some participants were excluded from albumin analysis due to missing blood test results at baseline. | Mean | Standard Deviation | g/dL |
|
| Body Mass Index (BMI) | Calculated as weight (kg) / height (m²). | BMI data were missing for one participant in the control group due to incomplete height or weight records at baseline. | Mean | Standard Deviation | kg/m² |
|
| Hand Grip Strength | Measured using dynamometer; dominant hand used. | Hand grip strength data were missing for three participants due to inability to complete the test or device-related issues at baseline. | Mean | Standard Deviation | kg |
|
| OG001 | Control Group | The control group receives usual care, which involves standard CKD education and consultation. Usual care: Nurses provide routine education and consultation |
|
|
| Secondary | Physical Activity Level Measured by IPAQ-Taiwan | 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. | Posted | Mean | Standard Deviation | MET-minutes/week | Baseline, 3 months, and 6 months post-intervention |
|
|
|
| Secondary | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 3 months, and 6 months post-intervention |
|
|
|
| Secondary | Nutritional Status Measured by MNA-SF | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months post-intervention |
|
|
|
| 1 |
| 60 |
| 1 |
| 60 |
| 0 |
| 60 |
| EG001 | Control Group | The control group receives usual care, which involves standard CKD education and consultation. | 0 | 60 | 0 | 60 | 0 | 60 |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| University or above |
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| widowed |
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| 6 months post-intervention |
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| 6 months post-intervention |
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| 6 months post-intervention |
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