Chronic Kidney Diseases, Health Behaviors, Patient Education
Conditions
Keywords
Chronic kidney disease, health-promoting, randomized controlled trial, tailored intervention, transtheoretical model
Brief summary
to compare the effectiveness of tailored TTM-based interventions (intervention group) compared to usual care (control group) on biomarkers of kidney function, physical indicators, adoption of health-promoting lifestyle behaviors, kidney disease knowledge, perceived self-efficacy, perceived benefits and barriers to physical activity changes, and quality of life among patients with early-stage CKD over a 30 month period.
Detailed description
A thirty-month clinical trial (ClinicalTrials.gov registration NCT01194518) was conducted from October 2010 through October 2013. The CONSORT checklist (Schulz et al., 2010) guided the study. Data were collected at baseline and at 6, 12, 18, 24, and 30 months post-intervention. Participants and Setting After obtaining approval to conduct the study from the Institutional Review Board, the nephrology case managers from the outpatient clinics of two medical centers in southern Taiwan were contacted and asked to refer patients to the study. Participants were included if they were at least 20 years old, 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. Upon obtaining written informed consent subjects were randomly assigned to the control or intervention group at a ratio of 1 to 1 using paper ballots. The Bureau of National Health Insurance (BNHI) in Taiwan launched the CKD care program for pre-ESRD care which suggested that CKD management and education depended on the stage of CKD (Chen et al., 2011). In addition, Taiwan established a medical system protocol to standardize and regulate pre-ESRD care with all medical expenditures covered by the National Health Insurance (NHI). Therefore, patients receive regular follow-ups as nephrology outpatients with the nephrology case managers providing usual care.
Interventions
BEHAVIORALLifestyle counseling Program
The tailored intervention made use of the 10 processes of change, important guides for developing intervention programs, which have received the most empirical support to date. The 10 processes include consciousness raising, dramatic relief, self-reevaluation, environmental reevaluation, self-liberation, social liberation, counterconditioning, stimulus control, reinforcement management, and helping relations. The different tailored interventions were based on the processes of change matched to the patient's stage of change, providing strategies that may be especially helpful to patients. According to the Lenio analysis of the TTM model of behavior change, the first five processes are used in the early stages, and the last five are used in the later stages.
Sponsors
National Cheng Kung University
National Cheng-Kung University Hospital
E-DA Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.at least 20 years old 2. diagnosed as stage 1-3 CKD (eGFR greater than ≧ 44 ml/min per 1.73 m2), 3. spoke Mandarin, 4.could be followed up every 6 months when they returned for a clinic outpatient visit. \-
Exclusion criteria
1. could not participate in moderate exercise 2. not able to verbalize understanding of the study 3. already enrolled in another program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months | The baseline and at 6, 12, 18, 24, and 30 months post intervention | 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. |
| The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months | The baseline and at 6, 12, 18, 24, and 30 months post intervention | 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. |
| The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months | The baseline and at 6, 12, 18, 24, and 30 months post intervention | 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. |
| The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months | The baseline and at 6, 12, 18, 24, and 30 months post intervention | 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. |
| The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months | The baseline and at 6, 12, 18, 24, and 30 months post intervention | 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. |
| The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months | The baseline and at 12, 24 months post intervention | 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. |
| The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months | The baseline and at 12, 24 months post intervention | 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. |
| The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months. | The baseline and at 12, 24 months post intervention | 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. |
| The Results of Environment QOL Scores From Baseline to 12, and 24 Months | The baseline and at 12, 24 months post intervention | 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. |
| The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months | The baseline and at 12, 24 months post intervention | 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. |
| The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months | The baseline and at 12, 24 months post intervention | 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. |
| The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months | The baseline and at 12, 24 months post intervention | 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. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORMiaofen Yen, Doctor
National Cheng Kung University
Participant flow
Recruitment details
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.
Pre-assignment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous age | 55.6 years STANDARD_DEVIATION 10.78 |
| Body Weight | 78.7 kg STANDARD_DEVIATION 14.1 |
| Disease-specific knowledge of renal protection checklist (RPK) | 92.30 units on a scale STANDARD_DEVIATION 10.87 |
| Glomerular filtration rate (eGFR) | 54.87 ml/min/1.73m2 STANDARD_DEVIATION 18.49 |
| Health Promotion Lifestyle Behaviors | 2.77 units on a scale STANDARD_DEVIATION 0.51 |
| Hip circumference | 104.3 cm STANDARD_DEVIATION 8.1 |
| Perceived barriers of physical activity | 44.18 units on a scale STANDARD_DEVIATION 15.02 |
| perceived benefits of physical activity | 70.13 units on a scale STANDARD_DEVIATION 8.85 |
| Perceived self-efficacy | 50.98 units on a scale STANDARD_DEVIATION 18.06 |
| Quality of Life ( WHOQOL-BREF) environment QOL domain | 14.46 units on a scale STANDARD_DEVIATION 2.29 |
| Quality of Life ( WHOQOL-BREF) physical health QOL domain | 14.37 units on a scale STANDARD_DEVIATION 2.34 |
| Quality of Life ( WHOQOL-BREF) psychological health QOL domain | 13.71 units on a scale STANDARD_DEVIATION 2.76 |
| Quality of Life ( WHOQOL-BREF) social relationships QOL domain | 14.28 units on a scale STANDARD_DEVIATION 2.37 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 39 Participants |
| Waist circumference | 98.6 cm STANDARD_DEVIATION 9.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
None listed