Self-CareNCT04199338
The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis
A study testing The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis in people with Self-Care and Self Efficacy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Web-based training based on the Self-Care Deficiency Theory has an effect on increasing self-care in in patients undergoing peritoneal dialysis. Web-based training based on Self-Care Deficiency Theory has an effect on increasing self-efficacy in patients undergoing peritoneal dialysis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Self-Care, Self Efficacy, Perceived Social Support
- What is being tested?
- The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who were receive peritoneal dialysis at Akdeniz University Hospital.
- Patients who receiving peritoneal dialysis treatment for at least one months
- Patients who were over 18 years of age,
- Patients who had orientation of individual, place and time
- Patients who were literate
- Patients who has Internet at home
Show all 9Show fewer
- Patients who has computer or mobile phone
- Patients who no barriers to written or verbal communication
- Patients who agree to participate in the study
Who cannot join
- Diagnosis of psychiatric illness
- Malignancy diagnosed
- Visually and hearing impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Adults Patients Receiving Peritoneal Dialysis Treatment
Web-based training based on the Self-Care Deficiency Theory has an effect on increasing self-care in in patients undergoing peritoneal dialysis.
Web-based training based on Self-Care Deficiency Theory has an effect on increasing self-efficacy in patients undergoing peritoneal dialysis.
Web-based education based on Self-Care Deficiency Theory has an effect on increasing perceived social support level in patients undergoing peritoneal dialysis.
Read the detailed description
In the study, which will last for 3 months, the patients in the intervention group will receive pre-test Web-based training based on the Self-Care Deficiency Theory. And an intervention group will be expected to use the website weekly. Also weekly reminder messages will be sent regularly.
Following the final test, individuals in the enterprise group will be asked to evaluate their views on the website in writing with the WAMMI test.
- Being tested
- The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis
- Keywords
- peritoneal dialysis,, Orem' self defiency theory, Nursing, Randomized Controlled Trial, Renal Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal DialysisOther
Also called Web Based Education Based on Self-Care Deficiency Theory
In the study, which will last for 3 months, the patients in the intervention group will receive pre-test Web-based training based on the Self-Care Deficiency Theory. And an intervention group will be expected to use the website weekly. Also weekly reminder messages will be sent regularly.
Following the final test, individuals in the enterprise group will be asked to evaluate their views on the website in writing with the WAMMI test.
| Study group | Role | What they receive |
|---|---|---|
| Randomized | Experimental | Randomized Receives: Other: The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Has an effect on self-care power.
Self-care Power Scale is a Likert-type scale that consists of 25 items and is scored from 0-2.
In the evaluation, low scores are considered to be good, high scores are not good self-care power.The scale was developed in Turkey.
Measured: 3 months
Has an effect on self-efficacy.
Self-efficacy scale have 10 expressions in the Turkish form and each receives scores ranging from 1 to 4. The lowest score obtained from the scale is evaluated as 10 and the highest score as 40. Self-efficacy score increases as the scale score increases.The scale was developed in Turkey.
Measured: 3 months
Has an effect on perceived social support
The perceived social support scale consisted of 12 items and each consisted of 3 groups regarding the source of the support consisting of 4 items. The higher the score, the higher the perceived social support.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jun 2019
- Primary completion20 Aug 2019
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self-CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a randomized controlled study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice CEYLAN, Akdeniz University
- Investigators
- Zeynep ÖZER, PhD, RN, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199338
- Sponsor's protocol ID
- University of Akdeniz
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will share
Publications
Rambod M, Rafii F. Perceived social support and quality of life in Iranian hemodialysis patients. J Nurs Scholarsh. 2010 Sep 1;42(3):242-9. doi: 10.1111/j.1547-5069.2010.01353.x.
PubMed 20738734Plantinga LC, Fink NE, Harrington-Levey R, Finkelstein FO, Hebah N, Powe NR, Jaar BG. Association of social support with outcomes in incident dialysis patients. Clin J Am Soc Nephrol. 2010 Aug;5(8):1480-8. doi: 10.2215/CJN.01240210. Epub 2010 Apr 29.
PubMed 20430940O'Shaughnessy M. Application of Dorothea Orem's Theory of Self-Care to the Elderly Patient on Peritoneal Dialysis. Nephrol Nurs J. 2014 Sep-Oct;41(5):495-7.
PubMed 26295092Ramezani T, Sharifirad G, Rajati F, Rajati M, Mohebi S. Effect of educational intervention on promoting self-care in hemodialysis patients: Applying the self-efficacy theory. J Educ Health Promot. 2019 Mar 14;8:65. doi: 10.4103/jehp.jehp_148_18. eCollection 2019.
PubMed 31008132
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Adults Patients Receiving Peritoneal Dialysis Treatment
- ClinicalTrials.gov ID
- NCT04199338
- Acronym / sponsor ID
- University of Akdeniz
- Keywords
- peritoneal dialysis,, Orem' self defiency theory, Nursing, Randomized Controlled Trial, Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Web-based training based on the Self-Care Deficiency Theory has an effect on increasing self-care in in patients undergoing peritoneal dialysis.
Web-based training based on Self-Care Deficiency Theory has an effect on increasing self-efficacy in patients undergoing peritoneal dialysis.
Web-based education based on Self-Care Deficiency Theory has an effect on increasing perceived social support level in patients undergoing peritoneal dialysis.
Detailed description
In the study, which will last for 3 months, the patients in the intervention group will receive pre-test Web-based training based on the Self-Care Deficiency Theory. And an intervention group will be expected to use the website weekly. Also weekly reminder messages will be sent regularly.
Following the final test, individuals in the enterprise group will be asked to evaluate their views on the website in writing with the WAMMI test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Randomized | Experimental | Other: The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal DialysisRandomized |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who were receive peritoneal dialysis at Akdeniz University Hospital.
- Patients who receiving peritoneal dialysis treatment for at least one months
- Patients who were over 18 years of age,
- Patients who had orientation of individual, place and time
- Patients who were literate
Key exclusion criteria (3 listed)
- Diagnosis of psychiatric illness
- Malignancy diagnosed
- Visually and hearing impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal DialysisAlso: Web Based Education Based on Self-Care Deficiency TheoryIn the study, which will last for 3 months, the patients in the intervention group will receive pre-test Web-based training based on the Self-Care Deficiency Theory. And an intervention group will be expected to use the website weekly. Also weekly reminder messages will be sent regularly. Following the final test, individuals in the enterprise group will be asked to evaluate their views on the website in writing with the WAMMI test. | Other | Randomized |
Primary outcome
Has an effect on self-care power.
Time frame: 3 months
Self-care Power Scale is a Likert-type scale that consists of 25 items and is scored from 0-2. In the evaluation, low scores are considered to be good, high scores are not good self-care power.The scale was developed in Turkey.
Has an effect on self-efficacy.
Time frame: 3 months
Self-efficacy scale have 10 expressions in the Turkish form and each receives scores ranging from 1 to 4. The lowest score obtained from the scale is evaluated as 10 and the highest score as 40. Self-efficacy score increases as the scale score increases.The scale was developed in Turkey.
Has an effect on perceived social support
Time frame: 3 months
The perceived social support scale consisted of 12 items and each consisted of 3 groups regarding the source of the support consisting of 4 items. The higher the score, the higher the perceived social support.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Background: PubMed 20738734Rambod M, Rafii F. Perceived social support and quality of life in Iranian hemodialysis patients. J Nurs Scholarsh. 2010 Sep 1;42(3):242-9. doi: 10.1111/j.1547-5069.2010.01353.x.
- Background: PubMed 20430940Plantinga LC, Fink NE, Harrington-Levey R, Finkelstein FO, Hebah N, Powe NR, Jaar BG. Association of social support with outcomes in incident dialysis patients. Clin J Am Soc Nephrol. 2010 Aug;5(8):1480-8. doi: 10.2215/CJN.01240210. Epub 2010 Apr 29.
- Background: PubMed 26295092O'Shaughnessy M. Application of Dorothea Orem's Theory of Self-Care to the Elderly Patient on Peritoneal Dialysis. Nephrol Nurs J. 2014 Sep-Oct;41(5):495-7.
- Background: PubMed 31008132Ramezani T, Sharifirad G, Rajati F, Rajati M, Mohebi S. Effect of educational intervention on promoting self-care in hemodialysis patients: Applying the self-efficacy theory. J Educ Health Promot. 2019 Mar 14;8:65. doi: 10.4103/jehp.jehp_148_18. eCollection 2019.
- Individual participant dataSharing planned: Yes. All collected IPD will share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep ÖZER, PhD, RN study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis in people with Self-Care and Self Efficacy, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Has an effect on self-care power. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199338, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.