CKD - Chronic Kidney Disease
Conditions
Brief summary
This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).
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.
Interventions
BEHAVIORALPACE 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.
BEHAVIORALUsual care
Nurses provide routine education and consultation
Sponsors
National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tilburg Frailty Indicator (TFI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Level Measured by IPAQ-Taiwan | 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. |
| Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 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. |
| Nutritional Status Measured by MNA-SF | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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
Pre-assignment details
A total of 120 participants were enrolled and assigned to study arms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Control Group The control group receives usual care, which involves standard CKD education and consultation. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | PACE Intervention | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 66.70 Years STANDARD_DEVIATION 13.25 | 69.10 Years STANDARD_DEVIATION 11.65 | 67.90 Years STANDARD_DEVIATION 12.48 |
| Body Mass Index (BMI) | 25.73 kg/m² STANDARD_DEVIATION 5.85 | 26.14 kg/m² STANDARD_DEVIATION 4.74 | 25.93 kg/m² STANDARD_DEVIATION 5.31 |
| Education Level High school or college | 27 Participants | 23 Participants | 50 Participants |
| Education Level Middle school or below | 22 Participants | 30 Participants | 52 Participants |
| Education Level University or above | 11 Participants | 7 Participants | 18 Participants |
| Estimated Glomerular Filtration Rate (eGFR) | 36.00 mL/min/1.73m² STANDARD_DEVIATION 23.63 | 39.92 mL/min/1.73m² STANDARD_DEVIATION 20.34 | 37.96 mL/min/1.73m² STANDARD_DEVIATION 22.94 |
| Hand Grip Strength | 23.93 kg STANDARD_DEVIATION 9.76 | 23.31 kg STANDARD_DEVIATION 10.82 | 23.62 kg STANDARD_DEVIATION 10.27 |
| Living Status lived alone | 11 Participants | 9 Participants | 20 Participants |
| Living Status living with family | 49 Participants | 51 Participants | 100 Participants |
| Marital Status married | 40 Participants | 35 Participants | 75 Participants |
| Marital Status single | 10 Participants | 9 Participants | 19 Participants |
| Marital Status widowed | 10 Participants | 16 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Serum Albumin | 4.30 g/dL STANDARD_DEVIATION 0.53 | 4.28 g/dL STANDARD_DEVIATION 0.38 | 4.29 g/dL STANDARD_DEVIATION 0.46 |
| Sex: Female, Male Female | 27 Participants | 30 Participants | 57 Participants |
| Sex: Female, Male Male | 33 Participants | 30 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 1 / 60 | 0 / 60 |
Outcome results
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.
Time frame: Baseline, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PACE Intervention | Tilburg Frailty Indicator (TFI) | Baseline | 5.38 score on a scale | Standard Deviation 2.62 |
| PACE Intervention | Tilburg Frailty Indicator (TFI) | 3 months post-intervention | 4.16 score on a scale | Standard Deviation 2.69 |
| PACE Intervention | Tilburg Frailty Indicator (TFI) | 6 months post-intervention | 4.43 score on a scale | Standard Deviation 2.81 |
| Control Group | Tilburg Frailty Indicator (TFI) | Baseline | 4.97 score on a scale | Standard Deviation 2.96 |
| Control Group | Tilburg Frailty Indicator (TFI) | 3 months post-intervention | 4.16 score on a scale | Standard Deviation 2.37 |
| Control Group | Tilburg Frailty Indicator (TFI) | 6 months post-intervention | 4.74 score on a scale | Standard Deviation 2.56 |
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.
Time frame: Baseline, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PACE Intervention | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | Baseline | 149 scores on a scale | Standard Deviation 19.93 |
| PACE Intervention | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 3 months post-intervention | 152.93 scores on a scale | Standard Deviation 19.71 |
| PACE Intervention | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 6 months post-intervention | 149.81 scores on a scale | Standard Deviation 24.35 |
| Control Group | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | Baseline | 144.6 scores on a scale | Standard Deviation 21.23 |
| Control Group | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 3 months post-intervention | 149.60 scores on a scale | Standard Deviation 20.21 |
| Control Group | Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version) | 6 months post-intervention | 142.46 scores on a scale | Standard Deviation 25.72 |
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.
Time frame: Baseline, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PACE Intervention | Nutritional Status Measured by MNA-SF | Baseline | 12.25 score on a scale | Standard Deviation 1.76 |
| PACE Intervention | Nutritional Status Measured by MNA-SF | 3 months post-intervention | 12.49 score on a scale | Standard Deviation 1.3 |
| PACE Intervention | Nutritional Status Measured by MNA-SF | 6 months post-intervention | 12.42 score on a scale | Standard Deviation 1.58 |
| Control Group | Nutritional Status Measured by MNA-SF | Baseline | 12.55 score on a scale | Standard Deviation 1.6 |
| Control Group | Nutritional Status Measured by MNA-SF | 3 months post-intervention | 12.59 score on a scale | Standard Deviation 1.61 |
| Control Group | Nutritional Status Measured by MNA-SF | 6 months post-intervention | 12.35 score on a scale | Standard Deviation 1.86 |
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.
Time frame: Baseline, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PACE Intervention | Physical Activity Level Measured by IPAQ-Taiwan | Baseline | 3650.88 MET-minutes/week | Standard Deviation 2057.09 |
| PACE Intervention | Physical Activity Level Measured by IPAQ-Taiwan | 3 months post-intervention | 3248.18 MET-minutes/week | Standard Deviation 1950.36 |
| PACE Intervention | Physical Activity Level Measured by IPAQ-Taiwan | 6 months post-intervention | 3588.53 MET-minutes/week | Standard Deviation 2117.56 |
| Control Group | Physical Activity Level Measured by IPAQ-Taiwan | Baseline | 3971.91 MET-minutes/week | Standard Deviation 3647.7 |
| Control Group | Physical Activity Level Measured by IPAQ-Taiwan | 3 months post-intervention | 3891.37 MET-minutes/week | Standard Deviation 2747.92 |
| Control Group | Physical Activity Level Measured by IPAQ-Taiwan | 6 months post-intervention | 3259.35 MET-minutes/week | Standard Deviation 2140.04 |