Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD

NCT01194518 | Completed Results DMC

• 1 other identifier: NSC992314B006048MY3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Health Behaviors; Patient Education

Keywords

Chronic kidney disease; health-promoting; randomized controlled trial; tailored intervention; transtheoretical model

Outcome Measures

Primary Outcomes (12)

• 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

• 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

Study Arms (2)

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.

Behavioral: Lifestyle counseling Program

Control group

NO INTERVENTION

Control group only received usual care.

Interventions

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.

Also known as: tailored interventions

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng Kung University: lead
• National Cheng-Kung University Hospital: collaborator
• E-DA Hospital: collaborator

Study Sites (1)

National Cheng Kung University

Tainan, 70101, Taiwan

Location

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Health Behavior

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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.

Results Point of Contact

• Title: Miaofen Yen, PhD, RN, FAAN
• Organization: National Cheng Kung University

miaofen@mail.ncku.edu.tw

+88662353535

Study Officials

• Miaofen Yen, Doctor

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, FAAN

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 3, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 28, 2026
• Results First Posted: May 28, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)