Condition category
Urological and Genital Diseases
Date applied
12/06/2012
Date assigned
26/06/2012
Last edited
26/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Without treatment, patients with chronic kidney disease (CKD) will experience deterioration in renal functions. Preventing the progression of CKD and avoiding early entry into the dialysis are urgent issues. The study attempted to develop a self-management education program based on the self-regulation theory and to assess whether and how it helped patients with early stage CKD to manage their condition.

Who can participate?
Patients with early stage CKD.

What does the study involve?
After informed consents were obtained, blood samples were taken and questionnaires were filled in. Participants received a five-week, group sessions self-management program based on self-regulation theory. Participants were pre-tested to establish a baseline (T0) and then there were three post-at 3 months (T1), 6 months (T2), and 12 months (T3) after the self-management program was delivered.

What are the possible benefits and risks of participating?
Participants who participate the intervention (i.e., self-management program) will learn how to self manage their CKD to prevent further deterioration.
There is no any known risk found in this study.

Where is the study run from?
Subjects were recruited from the following four hospitals in southern Taiwan:.
1. Kaohsiung Medical University Chung-Ho Memorial Hospital
2. Kaohsiung Municipal Hsiao-Kang Hospital
3. Chia-Yi Christian Hospital
4. Chi-Mei Medical Center

When is the study starting and how long is it expected to run for?
The study ran from September 2008 to December 2009, lasting 16 months.

Who is funding the study?
This study was supported by funds from the National Science Council, Taiwan (NSC95-2314-B-037-052-MY3).

Who is the main contact?
Chiu-Chu Lin
chiuchu@kmu.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chiu-Chu Lin

ORCID ID

Contact details

100 Shih-Chuan
1st Road
Kaohsiung
807
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of a self-management program on patients with early stage chronic kidney disease: a repeated measures longitudinal study

Acronym

Study hypothesis

Without intervention, patients with chronic kidney disease (CKD) will experience deterioration in renal functions. Preventing the progression of CKD and avoiding early entry into the dialysis are urgent issues.

Ethics approval

Kaohsiung Medical University Institutional Review Board, December 29, 2005, ref: KMUH-IRB-940359

Study design

One-group pretest-posttest repeated measures longitudinal study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact Chiu-Chu Lin, PhD RN, chiuchu@kmu.edu.tw to request a patient information sheet

Condition

Early stage chronic kidney disease

Intervention

The CKD self-management program designed by the research team was based on the self-regulation theory. Each study subject was scheduled for a five-week self-management program which included face-to-face sessions involving groups of 6 to 8 participants, and group sessions of 90-minute per week. After subjects watched the CKD self-management video, the lead investigator led subjects to discuss and learn about the self-regulation processes. Self-regulation activities were developed and used as models by study participants. By watching the examples demonstrated in the video, participants could learn new self-management strategies. At the end of each session, participants were given assignments to monitor and record their daily activities, using the self-monitoring workbook, from which they could find the possible causes or circumstances producing the problems.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. CKD self-efficacy
2. CKD self-management behavior

Measured at 3 months (T1), 6 months (T2), and 12months (T3) after the intervention of a self-management program.

Secondary outcome measures

1. Serum creatinine (SCr)
2. Glomerular filtration rate (GFR)

Measured at 3 months (T1), 6 months (T2), and 12months (T3) after the intervention of a self-management program.

Overall trial start date

01/09/2008

Overall trial end date

30/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Was diagnosed with CKD 1-3a stage six months or more prior to the study
2. Aged 18 years or older
3. Without visual or aural impairment
4. Spoke Taiwanese or Mandarin
5. Consented to fill out questionnaires and to blood tests in order to test the CKD progression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Of the 44 subjects recruited, 37 people consented to participate in this study. Finally, 33 subjects completed this study.

Participant exclusion criteria

Diagnosed with CKD 3b-5 stage

Recruitment start date

01/09/2008

Recruitment end date

30/12/2009

Locations

Countries of recruitment

Taiwan

Trial participating centre

100 Shih-Chuan
Kaohsiung
807
Taiwan

Sponsor information

Organisation

National Science Council (Taiwan)

Sponsor details

106
Sec. 2
Heping E. Rd
Taipei
10622
Taiwan

Sponsor type

Government

Website

http://web1.nsc.gov.tw/mp.aspx?mp=7

Funders

Funder type

Government

Funder name

National Science Council (Taiwan) (NSC95-2314-B-037-052-MY3)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes