The Effect of Education, Counseling, and Monitoring Provided to Individuals With Stoma Via a Mobile Application on Adaptation to Stoma and Quality of Lif
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Adaptation of Quality of Life Scale (AQLS) Total and Subscale Scores
研究概览
简要总结
This single-blind, parallel-group randomized controlled trial aims to evaluate the effects of a mobile app-based education, counseling, and follow-up program on stoma adaptation and quality of life in adults with a newly ostomy. The study will be conducted at the Stomatherapy Unit of Gazi University Health Research and Application Center (Ankara, Turkey). Participants meeting the inclusion criteria (n=66) will be assigned to intervention (mobile app support + standard care) and control (standard care only) groups in a 1:1 ratio via block randomization; participants will be kept unaware of their group assignment. Participants in the intervention group will download the "Stomatherapy-M" app on the day of discharge and will access structured educational content, receive nurse counseling (messaging and scheduled video calls), and share scheduled follow-up records regularly for six months. Follow-up frequency will be weekly in the first month, biweekly in the second month, and monthly in the following months. Primary outcomes; Adaptation to the stoma (Ostomy Adjustment Inventory) and stoma-related quality of life (Quality of Life Adaptation Scale) assessed at 15 days and 1, 3, and 6 months after discharge. App usability (MAUS) will be measured at 6 months only in the intervention group.
详细描述
This study is a single-blind, parallel-group randomized controlled trial designed to evaluate the effect of a mobile application-based education, counseling, and monitoring program on stoma adaptation and stoma-related quality of life in adults with a newly created ostomy.
The trial will be conducted at the Stomatherapy Unit of Gazi University Health Research and Application Center in Ankara, Türkiye.
Participants and sample size: Adults (≥18 years) undergoing ostomy surgery for the first time and expected to have a permanent ostomy or an ostomy lasting ≥6 months will be screened. Additional inclusion criteria include Turkish literacy, no major mental/physical/communication barriers, ownership of an iOS/Android smartphone with internet access, ability to use mobile applications, and WhatsApp use for digital form submission.
Individuals receiving concurrent stoma education/counseling from another institution or professional during follow-up will be excluded.
Based on power analysis (mixed ANOVA, Cohen f=0.40, α=0.05, power=99.7%, r=0.50), a minimum of 60 participants is required; allowing for ~10% attrition, the target enrollment is 66 participants (1:1 allocation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to group allocation. The intervention is delivered by the research team, therefore care providers and investigators are not blinded. Outcomes are self-reported through digital forms.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years Able to read and write Turkish Undergoing ostomy surgery for the first time Permanent ostomy or expected to remain for at least 6 months No major mental, physical, or communication impairment Owns an iOS/Android smartphone with active internet access Able to use mobile applications Uses WhatsApp for digital form submission during follow-up
排除标准
- •Receiving stoma-related education or counseling from another institution or professional during the study period
研究组 & 干预措施
Experimental
Participants will install the "Stomaterapi-M" mobile application on discharge day and will receive structured education (texts/videos), nurse counseling via in-app messaging and scheduled video calls, and planned monitoring for 6 months (weekly in month 1, bi-weekly in month 2, monthly in months 3-6) in addition to standard care.
干预措施: Stomaterapi-M Mobile Application Support (Behavioral)
Standard Care
Participants will receive routine stomatherapy education, counseling, and follow-up provided by the clinic. Outcome assessments will be completed digitally at the same time points as the intervention group, without access to the mobile application.
结局指标
主要结局
Adaptation of Quality of Life Scale (AQLS) Total and Subscale Scores
时间窗: Post-discharge Day 15, Month 1, Month 3, and Month 6
Ostomy Adjustment Inventory (OAI) Total Score
时间窗: Post-discharge Day 15, Month 1, Month 3, Month 6
次要结局
- Mobile Application Usability Scale (MAUS) Score(Month 6 (intervention group only))
研究者
Ferzan Kalaycı Emek
RESEARCH ASSISTANT
Gazi University