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Completed

NCT Number: NCT01194518

Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD

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.

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Key information

Conditions

Chronic Kidney Diseases Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Health Behaviors Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Education Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 70101, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • could not participate in moderate exercise
  • not able to verbalize understanding of the study
  • already enrolled in another program.

Treatment and study plan

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.

Other names: tailored interventions

Primary outcomes

  1. The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months

    Time frame: 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.

  2. The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months

    Time frame: 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.

  3. The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months

    Time frame: 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.

  4. The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months

    Time frame: 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.

  5. The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months

    Time frame: 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.

  6. The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months

    Time frame: 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.

  7. The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months

    Time frame: 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.

  8. The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.

    Time frame: 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.

  9. The Results of Environment QOL Scores From Baseline to 12, and 24 Months

    Time frame: 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.

  10. The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months

    Time frame: 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.

  11. The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months

    Time frame: 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.

  12. The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Collaborators

  • E-DA Hospital
  • National Cheng-Kung University Hospital

Registry information

Official study title

Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2010
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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