Examining the Effectiveness of a Mobile App on Self-care for a Colostomy

NCT05072379 | Unknown

• 1 other identifier: CHGH110-(IU)03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer has been one of the most common cancers in Taiwan. Using m-Health Apps to improve accessibility of personal health management has received greater attention and recognition. The purpose of this study is to develop a mobile App and understand its effects on improving colorectal cancer participants and their family caregivers' knowledge of colostomy care, anxiety, and quality of life as well as their satisfaction of the App. The study will use mixed methods as the study design in which content analysis will be used to identify the content suited for the App based on interviews with participants. A systematic research and development process will be utilized to design the text, videos, and images in the App's simulations to provide accurate, consistent, and complete knowledge of the skills needed for colostomy self-care and contending with any potential emergency. The results of this study not only will help colorectal participants and their family caregivers increase their knowledge of self-care for their colostomy, reduce anxiety, and improve quality of life, but it will also help the hospital to provide a high-quality and innovative technology for colorectal cancer participant and their family caregivers. Through this App, the quality of interaction and the rapport developed between healthcare professionals and participants will be enhanced, facilitating participant and family caregivers' responses to emergent situations and their endorsements toward the hospital. Ultimately, participants and their families will increase their satisfaction with the care.

Conditions

Colostomy

Keywords

m-Health; Colostomy; Anxiety; quality of life

Outcome Measures

Primary Outcomes (4)

• Change from the baseline score of the Stoma Care Awareness Assessment at the first and second months after discharge

  The knowledge of self-care for their colostomy The Stoma Care Cognition Assessment Form is developed by researchers based on related literature on stoma care. There are 10 items, including normal/abnormal judgments of stoma, replacement of stoma, nutrition, and activities, all of which are single-choice questions. Each question is counted with 10 points, and the total score is 100 points. The higher the score, the better the respondent's awareness of stoma care.

  Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.

• Change from the baseline score of the General Anxiety Disorder-7(GAD-7) at the first and second months after discharge

  The GAD-7 (Spitzer et al., 2006) is a one-dimensional instrument designed to detect generalized anxiety disorder symptoms as defined in the DSM-IV. The item scores range from 0 (not at all) to 3 (nearly every day), resulting in a sum score range from 0 to 21. The higher scores reflect greater anxiety severity.

  Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.

• Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) at the first and second months after discharge

  The nine items of the PHQ-9 are designed to capture the nine Diagnostic and Statistical Manual of Mental Disorders (DSM) symptom criteria for a major depressive episode. Response options on the items range from "not at all" (0 points) to "nearly every day"(3 points). As a severity measure, the PHQ-9 score can range from 0 to 27.

  Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.

• Change from the baseline score of the WHO Quality of Life-BREF,WHOQOL- BREF at the first and second months after discharge

  The Taiwan version of the WHOQOL-BREF questionnaire is based on the WHOQOL-BREF. The 26 questions of the WHOQOL-BREF are kept and translated into Chinese. In addition, two local questions are added to make a total of 28 questions. Divided into four categories, one is the physiological category (including physiology and independence), with a total of 7 questions; the second is the psychological category (including psychology, soul, religion, and personal beliefs), with a total of 6 questions; the third is the social relationship category, with a total of 4 questions; The fourth is the environmental project, a total of 9 questions; the other 2 questions are the overall assessment questions. Each question in the questionnaire is scored using Likert's five-point scale. The higher the score, the better the quality of life.

  Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.

Secondary Outcomes (1)

• The User Version of the Mobile Application Rating Scale: uMARS

  Data will be collected after discharge in the second month(T2).

Study Arms (2)

Mobile health app group

EXPERIMENTAL

routine care and mobile health app

Device: colostomy self-care app

control group

NO INTERVENTION

routine care

Interventions

colostomy self-care app DEVICE

The study will use mixed methods as the study design in which content analysis will be used to identify the content suited for the App based on interviews with participants. A systematic research and development process will be utilized to design the text, videos, and images in the App's simulations to provide accurate, consistent, and complete knowledge of the skills needed for colostomy self-care and contending with any potential emergency.

Mobile health app group

Eligibility Criteria

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

You may qualify if:

• At least 20 years old
• The main caregiver for women who are diagnosed with colorectal cancer for the first time and have a stoma
• Can use mobile phone to surf the Internet
• Fluent in listening, speaking, reading and writing Chinese
• Volunteer participation in this research

You may not qualify if:

• Those who are unconscious or unable to communicate clearly
• Those who have been diagnosed with mental illness

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (5)

• Dabas H, Sharma KK, Joshi P, Agarwala S. Video teaching program on management of colostomy: Evaluation of its impact on caregivers. J Indian Assoc Pediatr Surg. 2016 Apr-Jun;21(2):54-6. doi: 10.4103/0971-9261.176933.

  PMID: 27046974 BACKGROUND

• Kim H, Goldsmith JV, Sengupta S, Mahmood A, Powell MP, Bhatt J, Chang CF, Bhuyan SS. Mobile Health Application and e-Health Literacy: Opportunities and Concerns for Cancer Patients and Caregivers. J Cancer Educ. 2019 Feb;34(1):3-8. doi: 10.1007/s13187-017-1293-5.

  PMID: 29139070 BACKGROUND

• Putranto D, Rochmawati E. Mobile applications for managing symptoms of patients with cancer at home: A scoping review. Int J Nurs Pract. 2020 Aug;26(4):e12842. doi: 10.1111/ijn.12842. Epub 2020 Apr 29.

  PMID: 32347599 BACKGROUND

• Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.

  PMID: 27287964 BACKGROUND

• Sun V, Ercolano E, McCorkle R, Grant M, Wendel CS, Tallman NJ, Passero F, Raza S, Cidav Z, Holcomb M, Weinstein RS, Hornbrook MC, Krouse RS. Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Contemp Clin Trials. 2018 Jan;64:167-172. doi: 10.1016/j.cct.2017.10.008. Epub 2017 Oct 16.

  PMID: 29051047 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ya-Ling Hung, BS

  Cheng-Hsin General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Ling Hung, BS

CONTACT

+886920250932; enso680710@yahoo.com.tw

Chun-Yi Tai, Ph.D

CONTACT

+886-2-2822-7101; yii@ntunhs.edu.tw

Study Design

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

Model Details: 1. mobile health app group 2. control group

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: October 8, 2021
• Study Start: March 19, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)