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

The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Ostomy; Web Based Patient Education
• Intervention / Treatment: Other: Implementation of web-based patient education

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Üsküdar, Istanbul, Turkey
      • Saglik Bilimleri Universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
No Intervention: Control group; The clinical routine was applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Change from quality of life level at one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from stoma care knowledge level at one day

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): February 10, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 59491012-604.01.02; 31701 (Other Identifier: Istanbul University, Cerrahpasa)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No