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| Name | Class |
|---|---|
| National Cheng-Kung University Hospital | OTHER |
| E-DA Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention groups completed the stage-of-change and readiness-to-change assessments. Intervention groups were provided tailored interventions based on the premise that patient response to physical activity in stages for lifestyle counseling from baseline, 6, 12,18 24, and 30 months. |
|
| Control group | No Intervention | Control group only received usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle counseling Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months | 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 baseline and at 6, 12, 18, 24, and 30 months post intervention |
| The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months | 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 baseline and at 6, 12, 18, 24, and 30 months post intervention |
| The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months | 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 baseline and at 6, 12, 18, 24, and 30 months post intervention |
| The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months | 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 baseline and at 6, 12, 18, 24, and 30 months post intervention |
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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.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miaofen Yen, Doctor | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University | Tainan | 70101 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31496632 | Background | Araujo-Soares V, Hankonen N, Presseau J, Rodrigues A, Sniehotta FF. Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview. Eur Psychol. 2019;24(1):7-25. doi: 10.1027/1016-9040/a000330. Epub 2018 Aug 16. | |
| 24580088 | Background | Barzin M, Hosseinpanah F, Serahati S, Salehpour M, Nassiri AA, Azizi F. Changes in waist circumference and incidence of chronic kidney disease. Eur J Clin Invest. 2014 May;44(5):470-6. doi: 10.1111/eci.12253. |
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De-identified individuals participants data for all primary and secondary outcome measures.
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | ml/min/1.73 m2 | The baseline and at 6, 12, 18, 24, and 30 months post intervention |
|
30 months
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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 | Intervention Group | The intervention session started with:
|
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The data are not representative of all CKD patients, as the study sample had a male overrepresentation and the subjects were all in stages 1-3.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miaofen Yen, PhD, RN, FAAN | National Cheng Kung University | +88662353535 | 5823 | miaofen@mail.ncku.edu.tw |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
|
| 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 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 baseline and at 6, 12, 18, 24, and 30 months post intervention |
| The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months | 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 baseline and at 12, 24 months post intervention |
| The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months | 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 baseline and at 12, 24 months post intervention |
| The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months. | 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 baseline and at 12, 24 months post intervention |
| The Results of Environment QOL Scores From Baseline to 12, and 24 Months | 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 baseline and at 12, 24 months post intervention |
| The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months | 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 baseline and at 12, 24 months post intervention |
| The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months | 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 baseline and at 12, 24 months post intervention |
| The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months | 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. | The baseline and at 12, 24 months post intervention |
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| BG001 | Control Group | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Glomerular filtration rate (eGFR) | Mean | Standard Deviation | ml/min/1.73m2 |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Hip circumference | Mean | Standard Deviation | cm |
|
| Health Promotion Lifestyle Behaviors | Health promotion lifestyle was measured by the 52-item Health-Promoting Lifestyle-II (HPLP-II) Chinese questionnaire. Each item is scored on a Likert scale from 1 "never" to 4 "routine behavior." A score for an overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items. Higher scores indicated better health-promoting lifestyle behaviors. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life ( WHOQOL-BREF) | The QOL was evaluated using the 26 items WHOQOL-BREF Taiwan Version. Each item of the WHOQOL-BREF is scored from 1 to 5 on a response scale. The WHOQOL-BREF Taiwanese version incorporates four subscales: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Each subscale's scores for the WHOQOL were a minimum of 4 to a maximum of 20 scores according to guidelines. A higher score indicates a better QOL. | Mean | Standard Deviation | units on a scale |
|
| Disease-specific knowledge of renal protection checklist (RPK) | The disease-specific knowledge of renal protection checklist (RPK) was used to measure kidney disease knowledge. The RPK checklist consists of 20 items over three domains: renal function Protection (11 items), knowledge of Chinese herbal medicine related to renal function (5 items), and CKD diet (4 items). Each item is scored as 'correct' or 'incorrect' with each correct answer awarded five for a total score from 0 to 100; higher scores indicating better knowledge of renal function protection. | Mean | Standard Deviation | units on a scale |
|
| Perceived self-efficacy | The perceived self-efficacy scale was used to measure perceived self-efficacy for physical activity. Fifteen items are answered on a 6 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. | Mean | Standard Deviation | units on a scale |
|
| perceived benefits of physical activity | The Decisional Balance Scale (DBS) measures subjects' perceived physical activity, benefits and barriers on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The DBS includes the benefits to changing physical activity behaviors (14 items) and barriers to changing physical activity behaviors (15 items). A high score in either part means that the patient perceives changing physical activity as a benefit or a barrier, respectively. The total scores from a 1 minimum of 14 to a maximum of 84. | Mean | Standard Deviation | units on a scale |
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| Perceived barriers of physical activity | The Decisional Balance Scale (DBS) measures subjects' perceived physical activity, benefits and barriers on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The DBS includes the benefits to changing physical activity behaviors (14 items) and barriers to changing physical activity behaviors (15 items). A high score in either part means that the patient perceives changing physical activity as a benefit or a barrier, respectively. The total scores from a 1minimum of 15 to a maximum of 90. | Mean | Standard Deviation | units on a scale |
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| OG001 | Control Group | 1.Participants received usual care. 2.The counseling provided brief verbal information about maintaining the therapeutic regimen, reducing salt, smoking cessation, and reducing alcohol consumption. There was no structured program, and written materials were not provided. |
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| Primary | The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | cm | The baseline and at 6, 12, 18, 24, and 30 months post intervention |
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| Primary | The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | cm | The baseline and at 6, 12, 18, 24, and 30 months post intervention |
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| Primary | The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 6, 12, 18, 24, and 30 months post intervention |
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| Primary | 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 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 6, 12, 18, 24, and 30 months post intervention |
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| Primary | The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| Primary | The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| Primary | The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months. | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| Primary | The Results of Environment QOL Scores From Baseline to 12, and 24 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| Primary | The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| Primary | The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| Primary | The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months | 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. | Intend to Treat population (all participants assign to intervention or control group). | Posted | Mean | Standard Deviation | score on a scale | The baseline and at 12, 24 months post intervention |
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| 0 |
| 60 |
| 0 |
| 60 |
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| 60 |
| EG001 | Control Group | 1.Participants received usual care. 2.The counseling provided brief verbal information about maintaining the therapeutic regimen, reducing salt, smoking cessation, and reducing alcohol consumption. There was no structured program, and written materials were not provided. | 0 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided
| 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 |
| D001519 | Behavior |
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