The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study

NCT ID: NCT02076256

Last Updated: 2014-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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Helping relationships from significant others may assist patients with chronic kidney diseases to exercise health behaviors. Patients will adhere on the suggestions from medical staff and perform health lifestyle to maintain healthy behavior. The progress of the disease may be delayed.

The research is a 3-year study to explore the influence of helping relationships on healthy behaviors among patients with chronic kidney disease. Building on the findings from the past three years study and the literature on trans-theoretical Model, helping relationships will be articulated. A helping relation intervention will be applied to evaluate its effect on healthy lifestyle and quality of life.

The first year study will be a survey design. An instrument to measure the helping relationship will be established and tested. Total of 200 participants will be recruited to test the reliability and validity of the instrument. After evaluating the psychometric properties of the instrument, items may be revised according to the results. The second year of research will be a cross-section study. Of 250 subjects will be recruited to explore the correlations between helping relationships, healthy life styles, and quality of life. Data will be analyzed using hierarchical linear regression. In the third year, an experimental design will be applied to test the effect of a helping relationship intervention. One hundred and twenty subjects will be recruited and randomly assigned to the experimental and the control group for 60 subjects in each group. The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

The helping relationships intervention program

The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.

Group Type EXPERIMENTAL

The helping relationships intervention program

Intervention Type BEHAVIORAL

Interventions

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The helping relationships intervention program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 20 years and older
* diagnosed with chronic kidney disease stage 1 to 4 or GFR≧30ml/min/1.73m2
* patients who has significant others
* patients who can speak Mandarin or Taiwanese

Exclusion Criteria

* Patient who limited to exercise
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

E-DA Hospital

OTHER

Sponsor Role collaborator

National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Miaofen Yen

PhD, RN, FAAN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miaofen Yen

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

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National Cheng Kung University

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Miaofen Yen

Role: CONTACT

+886-6-2353535 ext. 5823

Facility Contacts

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Miaofen Yen, Doctor

Role: primary

886-6-2353535 ext. 5823

Other Identifiers

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NSC102-2314-B-006-013-MY3

Identifier Type: -

Identifier Source: org_study_id

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