Effects of a self-management program on patients with early stage chronic kidney disease
| ISRCTN | ISRCTN48085815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48085815 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/06/2012
- Registration date
- 26/06/2012
- Last edited
- 26/06/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
100 Shih-Chuan
1st Road
Kaohsiung
807
Taiwan
Study information
| Study design | One-group pretest-posttest repeated measures longitudinal study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please contact Chiu-Chu Lin, PhD RN, chiuchu@kmu.edu.tw to request a patient information sheet |
| Scientific title | Effects of a self-management program on patients with early stage chronic kidney disease: a repeated measures longitudinal study |
| Study objectives | 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(s) | Kaohsiung Medical University Institutional Review Board, December 29, 2005, ref: KMUH-IRB-940359 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2008 |
| Completion date | 30/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Of the 44 subjects recruited, 37 people consented to participate in this study. Finally, 33 subjects completed this study. |
| Key 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 |
| Key exclusion criteria | Diagnosed with CKD 3b-5 stage |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 30/12/2009 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
807
Taiwan
Sponsor information
Government
106, Sec. 2
Heping E. Rd
Taipei
10622
Taiwan
| Website | http://web1.nsc.gov.tw/mp.aspx?mp=7 |
|---|---|
"ROR" |
https://ror.org/02kv4zf79 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
