Trial Outcomes & Findings for Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD (NCT NCT01194518)
NCT ID: NCT01194518
Last Updated: 2026-05-28
Results Overview
The eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) formula (eGFR (ml/min/1.73 m2) = 186 × (SCr)-1.154 × (Age)-0.203 × (0.742 if female) (National Kidney Foundation, 2002). The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
COMPLETED
NA
120 participants
The baseline and at 6, 12, 18, 24, and 30 months post intervention
2026-05-28
Participant Flow
Included if they were at least 20 years, diagnosed with stages 1 to 3 CKD, spoke Mandarin, and could be followed up every 6 months when they returned for an outpatient visit. Patients who were unable to participate in moderate exercise, unable to verbalize that they understood the study, or were already enrolled in another program were excluded.
Research assistant explained the study purpose and procedure and obtained written informed consent. After completion baseline collecting, the research assistant used a paper ballot to randomly assign subjects to either the tailored intervention or a usual-care intervention in a ratio of 1:1. The subjects provided baseline data, and physical
Participant milestones
| Measure |
Lifestyle Counseling Program
The data collected from 2010 August to 2013 July. Subjects assigned to the intervention group received pre-ESRD usual care by a CKD case manager and six face-to-face tailored sessions, each lasting 30 minutes with a trained research nurse with 3 years of clinical nephrology experience. The intervention varied according to the stage of change assessment. The participants self-reported stage of change was determined by adapting a TTM staging inventory that includes five statements reflecting the five stages of change
|
Usual Care
subjects randomized to the control group received usual care by the CKD manager of the outpatient clinic visit. In addition, control subjects were offered 10-20 minutes of face-to-face counseling with a research assistant in a private room where focus on provided brief verbal information about maintenance of the therapeutic regimen, reducing salt, smoking cessation, and reducing alcohol consumption. There was no structured program or the provide of written material to participants. All data collection before instructions at each time period.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
52
|
51
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Lifestyle Counseling Program
The data collected from 2010 August to 2013 July. Subjects assigned to the intervention group received pre-ESRD usual care by a CKD case manager and six face-to-face tailored sessions, each lasting 30 minutes with a trained research nurse with 3 years of clinical nephrology experience. The intervention varied according to the stage of change assessment. The participants self-reported stage of change was determined by adapting a TTM staging inventory that includes five statements reflecting the five stages of change
|
Usual Care
subjects randomized to the control group received usual care by the CKD manager of the outpatient clinic visit. In addition, control subjects were offered 10-20 minutes of face-to-face counseling with a research assistant in a private room where focus on provided brief verbal information about maintenance of the therapeutic regimen, reducing salt, smoking cessation, and reducing alcohol consumption. There was no structured program or the provide of written material to participants. All data collection before instructions at each time period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
Baseline Characteristics
Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD
Baseline characteristics by cohort
| Measure |
Intervention Group
n=60 Participants
The intervention group received pre-ESRD usual care from a CKD case manager and six face-to-face tailored sessions, each lasting 30 minutes with a trained research nurse with 3 years of clinical nephrology experience. The intervention varied according to the stage of change assessment. The participant's self-reported stage of change was determined by adapting a TTM staging inventory that includes five statements reflecting the five stages of change
|
Control Group
n=60 Participants
The control group received the usual care from the CKD manager of the outpatient clinic visit. In addition, control subjects were offered 10-20 minutes of face-to-face counseling with a research assistant in a private room where the focus was on providing brief verbal information about maintenance of the therapeutic regimen, reducing salt, smoking cessation, and reducing alcohol consumption. There was no structured program or the provide of written material to participants. All data collection before instructions at each time period.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
55.6 years
STANDARD_DEVIATION 10.78 • n=51 Participants
|
61.0 years
STANDARD_DEVIATION 10.98 • n=14 Participants
|
58.3 years
STANDARD_DEVIATION 11.17 • n=65 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=51 Participants
|
13 Participants
n=14 Participants
|
34 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=51 Participants
|
47 Participants
n=14 Participants
|
86 Participants
n=65 Participants
|
|
Glomerular filtration rate (eGFR)
|
55.2 ml/min/1.73m2
STANDARD_DEVIATION 19.2 • n=51 Participants
|
54.6 ml/min/1.73m2
STANDARD_DEVIATION 18.0 • n=14 Participants
|
54.87 ml/min/1.73m2
STANDARD_DEVIATION 18.49 • n=65 Participants
|
|
Body Weight
|
74.3 kg
STANDARD_DEVIATION 8.8 • n=51 Participants
|
78.7 kg
STANDARD_DEVIATION 14.1 • n=14 Participants
|
76.5 kg
STANDARD_DEVIATION 12.9 • n=65 Participants
|
|
Waist circumference
|
93.2 cm
STANDARD_DEVIATION 8.6 • n=51 Participants
|
98.6 cm
STANDARD_DEVIATION 9.4 • n=14 Participants
|
95.9 cm
STANDARD_DEVIATION 9.35 • n=65 Participants
|
|
Hip circumference
|
102.2 cm
STANDARD_DEVIATION 7.5 • n=51 Participants
|
104.3 cm
STANDARD_DEVIATION 8.1 • n=14 Participants
|
103.3 cm
STANDARD_DEVIATION 7.9 • n=65 Participants
|
|
Health Promotion Lifestyle Behaviors
|
2.77 units on a scale
STANDARD_DEVIATION 0.51 • n=51 Participants
|
2.62 units on a scale
STANDARD_DEVIATION 0.49 • n=14 Participants
|
2.69 units on a scale
STANDARD_DEVIATION 0.50 • n=65 Participants
|
|
Quality of Life ( WHOQOL-BREF)
physical health QOL domain
|
14.37 units on a scale
STANDARD_DEVIATION 2.34 • n=51 Participants
|
14.51 units on a scale
STANDARD_DEVIATION 2.50 • n=14 Participants
|
14.44 units on a scale
STANDARD_DEVIATION 2.41 • n=65 Participants
|
|
Quality of Life ( WHOQOL-BREF)
psychological health QOL domain
|
13.72 units on a scale
STANDARD_DEVIATION 2.88 • n=51 Participants
|
13.69 units on a scale
STANDARD_DEVIATION 2.67 • n=14 Participants
|
13.71 units on a scale
STANDARD_DEVIATION 2.76 • n=65 Participants
|
|
Quality of Life ( WHOQOL-BREF)
social relationships QOL domain
|
14.28 units on a scale
STANDARD_DEVIATION 2.37 • n=51 Participants
|
13.62 units on a scale
STANDARD_DEVIATION 2.64 • n=14 Participants
|
13.95 units on a scale
STANDARD_DEVIATION 2.52 • n=65 Participants
|
|
Quality of Life ( WHOQOL-BREF)
environment QOL domain
|
14.55 units on a scale
STANDARD_DEVIATION 2.36 • n=51 Participants
|
14.38 units on a scale
STANDARD_DEVIATION 2.23 • n=14 Participants
|
14.46 units on a scale
STANDARD_DEVIATION 2.29 • n=65 Participants
|
|
Disease-specific knowledge of renal protection checklist (RPK)
|
94.61 units on a scale
STANDARD_DEVIATION 8.24 • n=51 Participants
|
92.30 units on a scale
STANDARD_DEVIATION 10.87 • n=14 Participants
|
93.47 units on a scale
STANDARD_DEVIATION 9.70 • n=65 Participants
|
|
Perceived self-efficacy
|
53.48 units on a scale
STANDARD_DEVIATION 16.99 • n=51 Participants
|
50.98 units on a scale
STANDARD_DEVIATION 18.06 • n=14 Participants
|
52.23 units on a scale
STANDARD_DEVIATION 17.51 • n=65 Participants
|
|
perceived benefits of physical activity
|
71.28 units on a scale
STANDARD_DEVIATION 7.17 • n=51 Participants
|
68.98 units on a scale
STANDARD_DEVIATION 10.20 • n=14 Participants
|
70.13 units on a scale
STANDARD_DEVIATION 8.85 • n=65 Participants
|
|
Perceived barriers of physical activity
|
44.13 units on a scale
STANDARD_DEVIATION 15.82 • n=51 Participants
|
44.22 units on a scale
STANDARD_DEVIATION 14.32 • n=14 Participants
|
44.18 units on a scale
STANDARD_DEVIATION 15.02 • n=65 Participants
|
PRIMARY outcome
Timeframe: The baseline and at 6, 12, 18, 24, and 30 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) formula (eGFR (ml/min/1.73 m2) = 186 × (SCr)-1.154 × (Age)-0.203 × (0.742 if female) (National Kidney Foundation, 2002). The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
baseline
|
78.7 ml/min/1.73 m2
Standard Deviation 14.06
|
74.3 ml/min/1.73 m2
Standard Deviation 8.77
|
|
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
6 Month
|
79.20 ml/min/1.73 m2
Standard Deviation 15.39
|
74.04 ml/min/1.73 m2
Standard Deviation 9.21
|
|
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
12 Month
|
79.16 ml/min/1.73 m2
Standard Deviation 15.36
|
74.41 ml/min/1.73 m2
Standard Deviation 9.35
|
|
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
18 Month
|
79.45 ml/min/1.73 m2
Standard Deviation 15.83
|
74.85 ml/min/1.73 m2
Standard Deviation 9.51
|
|
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
24 Month
|
78.33 ml/min/1.73 m2
Standard Deviation 14.55
|
74.34 ml/min/1.73 m2
Standard Deviation 8.96
|
|
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
30 Month
|
78.39 ml/min/1.73 m2
Standard Deviation 15.13
|
74.97 ml/min/1.73 m2
Standard Deviation 9.31
|
PRIMARY outcome
Timeframe: The baseline and at 6, 12, 18, 24, and 30 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
Waist circumference in centimeters was measured at the level midway between the lowest rib margin and the iliac crest at baseline, 6, 12, 18, 24, and 30 months for each intervention. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
baseline
|
98.6 cm
Standard Deviation 9.35
|
93.2 cm
Standard Deviation 8.63
|
|
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
6 month
|
98.7 cm
Standard Deviation 9.49
|
92.88 cm
Standard Deviation 8.774
|
|
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
12 month
|
99.23 cm
Standard Deviation 9.54
|
93.21 cm
Standard Deviation 9.54
|
|
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
18 month
|
99.13 cm
Standard Deviation 9.84
|
93.49 cm
Standard Deviation 9.45
|
|
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
24 month
|
98.96 cm
Standard Deviation 9.13
|
92.57 cm
Standard Deviation 9.45
|
|
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
30 month
|
99.27 cm
Standard Deviation 9.28
|
91.96 cm
Standard Deviation 9.49
|
PRIMARY outcome
Timeframe: The baseline and at 6, 12, 18, 24, and 30 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
Hip circumference was measured at the widest area over the trochanters at 6, 12, 18, 24, and 30 months of every intervention. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
baseline
|
104.33 cm
Standard Deviation 8.11
|
102.24 cm
Standard Deviation 7.46
|
|
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
6 months
|
104.34 cm
Standard Deviation 8.39
|
101.81 cm
Standard Deviation 6.54
|
|
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
12 months
|
103.94 cm
Standard Deviation 8.34
|
101.59 cm
Standard Deviation 7.50
|
|
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
18 months
|
102.85 cm
Standard Deviation 7.35
|
101.90 cm
Standard Deviation 7.63
|
|
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
24 months
|
103.28 cm
Standard Deviation 7.62
|
101.25 cm
Standard Deviation 8.06
|
|
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
30 monyths
|
103.51 cm
Standard Deviation 8.07
|
100.31 cm
Standard Deviation 7.65
|
PRIMARY outcome
Timeframe: The baseline and at 6, 12, 18, 24, and 30 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The HPLP-II is validated, Self-report questionnaires Health promotion lifestyle was measured by the 52-item Health-Promoting Lifestyle-II (HPLP-II) Chinese questionnaire. The total scores of the HPLP-II are determined by calculating a mean item response. The HPLP-II uses mean sums of scale items to remain the 1 to 4 metric of item. Higher scores indicated better health-promoting lifestyle behaviors. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
Baseline
|
2.59 score on a scale
Standard Deviation 0.40
|
2.68 score on a scale
Standard Deviation 0.50
|
|
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
6 months
|
2.58 score on a scale
Standard Deviation 0.46
|
2.66 score on a scale
Standard Deviation 0.50
|
|
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
12 months
|
2.66 score on a scale
Standard Deviation 0.50
|
2.74 score on a scale
Standard Deviation 0.50
|
|
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
18 months
|
2.64 score on a scale
Standard Deviation 0.54
|
2.78 score on a scale
Standard Deviation 0.52
|
|
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
24 months
|
2.62 score on a scale
Standard Deviation 0.54
|
2.86 score on a scale
Standard Deviation 0.52
|
|
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
30 months
|
2.62 score on a scale
Standard Deviation 0.50
|
2.90 score on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: The baseline and at 6, 12, 18, 24, and 30 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The renal protection checklist (RPK) is validated, Self-report questionnaires a disease-specific knowledge of renal protection checklist were developed by Yen, Huang, and Teng in 2008. The checklist consists of 20 items including three domains: renal function protection (11 items), knowledge of Chinese herbal medicine related to renal function (5 items), and diet with CKD (4 items). Item responses were "true" or "false." Each item is scored with 5 points for each correct answer. The total scores for the checklist range from 0-100. Higher scores indicate higher knowledge of renal function protection. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
Baseline
|
89.0 score on a scale
Standard Deviation 12.91
|
92.75 score on a scale
Standard Deviation 7.33
|
|
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
6 months
|
89.04 score on a scale
Standard Deviation 12.59
|
89.32 score on a scale
Standard Deviation 13.08
|
|
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
12 months
|
92.18 score on a scale
Standard Deviation 8.43
|
92.04 score on a scale
Standard Deviation 7.47
|
|
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
18 months
|
93.18 score on a scale
Standard Deviation 7.03
|
96.55 score on a scale
Standard Deviation 5.17
|
|
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
24 months
|
93.37 score on a scale
Standard Deviation 13.96
|
96.89 score on a scale
Standard Deviation 5.30
|
|
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
30 months
|
97.94 score on a scale
Standard Deviation 3.90
|
99.04 score on a scale
Standard Deviation 2.22
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results presented the physical health QOL scores at each time point from baseline to 12, and 24 months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
Baseline
|
14.51 score on a scale
Standard Deviation 2.50
|
14.37 score on a scale
Standard Deviation 2.34
|
|
The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
12 months
|
14.27 score on a scale
Standard Deviation 2.51
|
14.63 score on a scale
Standard Deviation 2.49
|
|
The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
24 months
|
14.06 score on a scale
Standard Deviation 2.70
|
14.37 score on a scale
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the psychological health QOL scores from baseline to 12, and 24 Months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
Baseline
|
13.69 score on a scale
Standard Deviation 2.67
|
13.72 score on a scale
Standard Deviation 2.88
|
|
The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
12 months
|
14.05 score on a scale
Standard Deviation 2.76
|
13.47 score on a scale
Standard Deviation 3.02
|
|
The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
24 months
|
13.58 score on a scale
Standard Deviation 2.74
|
13.37 score on a scale
Standard Deviation 2.79
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the Social Relationships QOL scores at each time point from baseline to 12, and 24 months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
Baseline
|
13.62 score on a scale
Standard Deviation 2.64
|
14.28 score on a scale
Standard Deviation 2.37
|
|
The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
12 months
|
13.87 score on a scale
Standard Deviation 2.58
|
14.04 score on a scale
Standard Deviation 2.64
|
|
The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
24 months
|
13.58 score on a scale
Standard Deviation 2.63
|
13.87 score on a scale
Standard Deviation 2.58
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the Environment QOL scores at each time point from baseline to 12, 24 months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Environment QOL Scores From Baseline to 12, and 24 Months
Baseline
|
14.38 score on a scale
Standard Deviation 2.23
|
14.55 score on a scale
Standard Deviation 2.36
|
|
The Results of Environment QOL Scores From Baseline to 12, and 24 Months
12 months
|
14.30 score on a scale
Standard Deviation 2.20
|
14.46 score on a scale
Standard Deviation 2.33
|
|
The Results of Environment QOL Scores From Baseline to 12, and 24 Months
24 months
|
14.12 score on a scale
Standard Deviation 2.22
|
14.41 score on a scale
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The Perceived self-efficacy of physical activity is validated, and the Self-report questionnaire. The perceived self-efficacy scale was used to measure perceived self-efficacy for physical activity. Fifteen items are answered on a six-point Likert scale ranging from 1 (completely uncertain) to 6 (completely certain). The total score ranges from 15-90, with a higher score representing greater perceived self-efficacy for physical activity. The results present the Perceived self-efficacy of physical activity scores at each time point from baseline to 12, and 24 months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
24 months
|
51.83 score on a scale
Standard Deviation 19.43
|
56.77 score on a scale
Standard Deviation 17.17
|
|
The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
Baseline
|
50.98 score on a scale
Standard Deviation 18.06
|
53.48 score on a scale
Standard Deviation 16.99
|
|
The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
12 months
|
50.85 score on a scale
Standard Deviation 18.64
|
58.25 score on a scale
Standard Deviation 17.06
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the benefits of changing physical activity behaviors (14 items) and the total score range from 14-84. The higher the scores represent the perceived benefits of physical activity is higher. The results present the Decisional balance (perceived benefits of physical activity) scores at each time point from baseline to 12, and 24 months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
Baseline
|
68.98 score on a scale
Standard Deviation 10.20
|
71.28 score on a scale
Standard Deviation 7.17
|
|
The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
12 month
|
71.51 score on a scale
Standard Deviation 8.99
|
72.11 score on a scale
Standard Deviation 8.05
|
|
The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
24 month
|
72.04 score on a scale
Standard Deviation 9.06
|
71.83 score on a scale
Standard Deviation 8.61
|
PRIMARY outcome
Timeframe: The baseline and at 12, 24 months post interventionPopulation: Intend to Treat population (all participants assign to intervention or control group).
The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the barrier of changing physical activity behaviors (15 items) and the total score range from 15-90. The higher the scores represent the perceived barrier to physical activity is higher. The results present the Decisional Balance (Perceived Barrier of Physical Activity) scores at each time point from baseline to 12, and 24 months.
Outcome measures
| Measure |
Control Group
n=60 Participants
Participants received usual care. Control group subjects were offered 10-20 minutes of face-to-face counseling by general health care in a private room.
|
Intervention Group
n=60 Participants
Participant received usual care provided by the CKD case manager, in addition to six face-to-face tailored sessions ( at baseline and at 6, 12, 18, 24, and 30 months ).
|
|---|---|---|
|
The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
Baseline
|
44.22 score on a scale
Standard Deviation 14.32
|
44.13 score on a scale
Standard Deviation 15.82
|
|
The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
12 months
|
45.24 score on a scale
Standard Deviation 14.87
|
42.56 score on a scale
Standard Deviation 14.12
|
|
The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
24 months
|
43.60 score on a scale
Standard Deviation 14.17
|
45.08 score on a scale
Standard Deviation 14.11
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Miaofen Yen, PhD, RN, FAAN
National Cheng Kung University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place