Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD

National Cheng Kung University

Status: Completed

Conditions: Chronic Kidney Diseases; Patient Education; Health Behaviors

Treatments: Behavioral: Lifestyle counseling Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01194518

NSC992314B006048MY3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle counseling Program

Control group

No Intervention group

Description:

Control group only received usual care.