The Effectiveness of APP Intervention on Home Self-care Ability and Quality of Life of Patients With Intestinal Stoma

NCT04943822 | Unknown

• 1 other identifier: fung
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the third leading cause of cancer-related deaths in Taiwan. In the United States, colorectal cancer is the third most common cancer diagnosis and mortality. According to the databases of the Bureau of National Health Insurance (BNHI), in 2003-2006, a total of 15,805 patients with colorectal surgery were included, and 27.11% were treated with ostomy, while 90.45% were colostomy and 9.55% were ileostomy. The domestic and foreign researches related to enterostomy mostly use cross-sectional research methods. The quality of life, knowledge of self-care and self-care needs of different postoperative methods of colorectal cancer have not been specifically improved for patients with enterostomy. The research on self-care ability and quality of life is for reference. In other countries, enterostomy care has gradually moved from medical institutions to community care, but community nurses generally have no relevant care skills. Advances in mobile technology such as smartphones and other mobile applications have created more opportunities for individuals to receive health-related treatments, anytime, anywhere and anywhere. In the United States, 93% of adult gastroenterology patients have smartphones in medical teaching hospitals, and most of them are interested in using health-related applications. In addition, previous studies have shown the potential benefits and efficacy of mobile devices for self-care patients in diabetes, obesity and cancer. However, there are limited studies on the feasibility and effectiveness of mobile applications for enterostomy care. Researchers want to explore the effectiveness of mobile device intervention on home self-care ability and quality of life of patients with intestinal stoma.

Conditions

Quality of Life; Mobile Apps; Ostomy

Outcome Measures

Primary Outcomes (1)

• Quality of life improvement

  The Enterostomy- QOL was comprised of 30 questionnaires, it covered seven domains: relations with family and friends, Sleep, activity, sexual activity, social relationship, physiology and psychology. The responses rated on a4-point scale Likert scale (1: extremely, 2: quite a lot, 3: somewhat, 4: not at all). The possible scores range was from 37 to 148. Higher scores indicated that patient had a higher level of quality of life.

  One and a half years

Secondary Outcomes (3)

• Self-care ability improvement

  One and a half years

• hospital medical record for clinical data

  One and a half years

• Stoma complications

  One and a half years

Study Arms (2)

conventional education service program

PLACEBO COMPARATOR

Including the written and verbal health education on preoperative preparation, stoma surgery and postoperative stoma care. At discharge, ET nurses offered teaching information and support for patients, including selection of pouching appliances, drug instructions, health education At each outpatient follow-up, both stomas and patients needed to be assessed. The condition of stoma and peristomal skin, nature and volume of effluent, date of pouch appliances and stoma complications were recorded by ET nurses.

Other: A new APP

mobile care device

EXPERIMENTAL

The participants in the intervention group were given the same routine care as the control group pre- and postoperatively. ET nurses taught patients and their family members how to use the home care mobile app before discharge. The home care mobile app was designed and developed for the discharged stoma patients by the research team and an information technology company in March 2021. Patients could receive stoma care from ET nurses through this mobile app at home, not just going to an outpatient clinic. The Major function modules of this mobile app were as follows: (a) appointment: The app users were able to complete the basic personal and medical information and make an appointment with the ET nurse; (b) photograph diagnosis: The ET nurses could make a diagnosis based on the patients' uploaded stoma photographs; and (c) consultation: Patients were able to contact their ET nurses for help and support. This mobile app was used to supplement the outpatient follow-up.

Other: A new APP

Interventions

A new APP OTHER

A new APP for prevention and treatment of complications of intestinal peristomal skin

conventional education service program; mobile care device

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with primary colorectal cancer;
• at least 20 years of age;
• able to read and speak Mandarin;

You may not qualify if:

• having other types of cancer; 2.having visual, hearing and/or cognitive impairments/mental disorders; 3.alcohol or drug abuse; 4.dying or having any surgical complications.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Hsing Fang Ko

Kaohsiung City, Taiwan

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 29, 2021
• Study Start: September 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)