CClinicalTrials.gg
CompletedNCT04561674Updated Sep 23, 2020

The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy

An interventional study of Implementation of web-based patient education in Web Based Patient Education, Quality of Life and Ostomy, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Dec 2017, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to develop, implement and determine the effects of web-based education programs for patients undergoing colostomy and ileostomy.The study is a randomized controlled experimental research with a pre-test post-test control group design. The study group of the research consisted of individuals, who have an abdominal stoma procedure at a Training and Research Hospital operating under the Ministry of Health in Turkey. 35 individuals were enrolled to the experiment and control groups (N=70). The study group of the hospital was determined as a result of the power analysis performed on an average number of 150 patients, on whom a stoma is opened within a year, with an estimated effect rate of 0.824 and a SD of 0.45, the power being 0.80 and confidence interval p:0.05, as a total of 50 patients, 25 in the experiment group and 25 in the control group. Taking into consideration the data loss that may be experienced, it was planned to enrol 35 individuals to the experiment group and 35 individuals to the control group. The patients were randomly assigned to each group. Homogeneity of patients randomized to the experiment and control groups was checked with a t-test. Research data were collected using an Information Form, Stoma Complications Assessment Form and City of Hope-Quality of Life-Ostomy Questionnaire and Stoma Care Knowledge Assessment Test.

Read the detailed description

The purpose of the study is to develop, implement and determine the effects of web-based education programs for patients undergoing colostomy and ileostomy.

The study is a randomized controlled experimental research with a pre-test post-test control group design. The study group of the research consisted of individuals, who have an abdominal stoma procedure at a Training and Research Hospital operating under the Ministry of Health in Turkey. 35 individuals were enrolled to the experiment and control groups (N=70). The study group of the hospital was determined as a result of the power analysis performed on an average number of 150 patients, on whom a stoma is opened within a year, with an estimated effect rate of 0.824 and a SD of 0.45, the power being 0.80 and confidence interval p:0.05, as a total of 50 patients, 25 in the experiment group and 25 in the control group. Taking into consideration the data loss that may be experienced, it was planned to enrol 35 individuals to the experiment group and 35 individuals to the control group. The patients were randomly assigned to each group. Homogeneity of patients randomized to the experiment and control groups was checked with a t-test. The stages of the research design were determined completely in accordance with the CONSORT diagram. Data were collected using an Information Form, Stoma Complications Assessment Form and City of Hope-Quality of Life-Ostomy Questionnaire and Stoma Care Knowledge Assessment Test. The study data were analysed with average, standard deviation, frequency, student t test, paired sample t test, variance analysis, Fisher's exact chi-square test, Fisher-Freeman-Halton test and Yates continuity correction test. Significance was assessed at a level of p\<0.05.

02

Conditions studied

  • Web Based Patient Education
  • Quality of Life
  • Ostomy
03

In context

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Colostomy and ileostomy patients,

  • eighteen years and over
  • literate
  • able to communicate
  • who can use computers and internet themselves or their caregivers

Exclusion criteria

Exclusion Criteria:

  • under eighteen years
  • illiterate
  • unable to communicate
  • who cannot use computers and the internet themselves or their caregivers
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Experimental Group

    The patients in the experimental group participated in "Web-Based Patient Education with Colostomy and Ileostomy" on computer between the third and seventh days after surgery. The cards with the website address, username and the website QR code were given to the patients in order to be able to receive education after discharge.The patient and her family received the training from any computer or smartphone connected to the internet.

    Other: Implementation of web-based patient education

  • No intervention
    Control group

    The clinical routine was applied to the control group.

Interventions

  • OtherImplementation of web-based patient education

    Web-Based Patient Education on Colostomy and Ileostomy (WBPECI) was developed in accordance with the principles of the ADDIE instructional design. The web-based education was designed in line with these learning objectives determined. The content of the website was developed in light of the opinions sought from five subject experts. The WBPECI content includes a total of 7 videos, 1 animation with sound, 1 forum and 1 consultation page

06

What researchers measure

Primary outcomes

  1. Quality of life level

    The City of Hope-Quality of Life-Ostomy Questionnaire was applied to the patients in the experimental."City of Hope-Quality of Life-Ostomy Questionnaire (COH-QOL-OQ)" designed and developed by City of Hope Pain and Palliative Care Resource Centre was first created in 1995 under the name "Quality of life in Cancer Patients".

    Time frame: Change from quality of life level at one month

Secondary outcomes

  1. Stoma Care Knowledge Level

    Stoma Care Knowledge Assessment Test was applied to the patients in the experimental group.This was prepared in light of the literature in order to assess the patients' level of knowledge on stoma. There are 17 items in the test. An example question is given below: The stool coming out of the stoma causes irritation on the skin surrounding it. The options are true, false and I do not know.

    Time frame: Change from stoma care knowledge level at one day

07

Study locations

1 site
  • Saglik Bilimleri Universitesi
    Üsküdar, Istanbul, Turkey
08

References and documents

Publications

  • Ang SG, Chen HC, Siah RJ, He HG, Klainin-Yobas P. Stressors relating to patient psychological health following stoma surgery: an integrated literature review. Oncol Nurs Forum. 2013 Nov;40(6):587-94. doi: 10.1188/13.ONF.587-594. PubMed 24161637 ↗
  • Ambe PC, Kurz NR, Nitschke C, Odeh SF, Moslein G, Zirngibl H. Intestinal Ostomy. Dtsch Arztebl Int. 2018 Mar 16;115(11):182-187. doi: 10.3238/arztebl.2018.0182. PubMed 29607805 ↗
  • Aquina CT, Iannuzzi JC, Probst CP, Kelly KN, Noyes K, Fleming FJ, Monson JR. Parastomal hernia: a growing problem with new solutions. Dig Surg. 2014;31(4-5):366-76. doi: 10.1159/000369279. Epub 2014 Dec 13. PubMed 25531238 ↗
  • Barr JE. Assessment and management of stomal complications: a framework for clinical decision making. Ostomy Wound Manage. 2004 Sep;50(9):50-2, 54, 56 passim. PubMed 15361633 ↗
  • Barrera M Jr, Glasgow RE, McKay HG, Boles SM, Feil EG. Do Internet-based support interventions change perceptions of social support?: An experimental trial of approaches for supporting diabetes self-management. Am J Community Psychol. 2002 Oct;30(5):637-54. doi: 10.1023/A:1016369114780. PubMed 12188054 ↗
  • Bass SB, Ruzek SB, Gordon TF, Fleisher L, McKeown-Conn N, Moore D. Relationship of Internet health information use with patient behavior and self-efficacy: experiences of newly diagnosed cancer patients who contact the National Cancer Institute's Cancer Information Service. J Health Commun. 2006 Mar;11(2):219-36. doi: 10.1080/10810730500526794. PubMed 16537289 ↗
  • Berger J, Topp R, Davis L, Jones J, Stewart L. Comparison of Web-based and face-to-face training concerning patient education within a hospital system. J Nurses Staff Dev. 2009 May-Jun;25(3):127-32; quiz 133-4. doi: 10.1097/NND.0b013e3181a56ba0. PubMed 19502896 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04561674
Lead sponsor
Saglik Bilimleri Universitesi
Collaborators
Istanbul University - Cerrahpasa
Responsible party
Hacer Ozel (Assistant Professor, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Sep 23, 2020
Start date
Dec 18, 2017
Primary completion
Feb 10, 2018
Completion
May 10, 2018
Last update
Sep 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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