Effect of a Structured Mobile Health Application on Medication Adherence and Quality of Life in Infertile Women Before Oocyte Pick-Up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in medication adherence score
研究概览
简要总结
This study aims to evaluate the effect of the OPUCARE system, a structured mobile health application used before oocyte pick-up (OPU), on medication adherence and quality of life in infertile women. The study will also examine the possible effect of the intervention on state anxiety.
Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive routine clinical care plus the OPUCARE system. The control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The intervention period will last approximately 2 weeks, from the start of medication treatment until oocyte pick-up. Medication adherence, quality of life, and state anxiety will be assessed before and after the intervention period.
详细描述
This study is planned as a prospective, two-arm, randomized controlled trial to evaluate the clinical effectiveness of the OPUCARE system in infertile women during the period before oocyte pick-up (OPU). The study is based on a quantitative research approach and will use a pretest-posttest control group design.
The study population will consist of infertile women scheduled for OPU at a university hospital infertility clinic in Istanbul, Turkey. The sample size was determined by power analysis. According to the analysis performed using G*Power 3.1.9.7, at least 27 participants are required in each group. Considering possible attrition, 30 participants will be recruited for each group, for a total sample size of 60 participants.
Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to the intervention group or the control group using a computer-generated randomization list prepared in advance. Because of the nature of the intervention, blinding of participants and implementers will not be possible. To reduce bias, data collection time points will be standardized, the same measurement tools will be applied to both groups in the same order, and analyses will be conducted according to a predefined statistical plan.
Participants in the intervention group will receive routine clinical care plus the OPUCARE system. Participants in the control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The OPUCARE system consists of two components: a patient-facing mobile support application and a clinic panel that allows healthcare professionals to monitor coded patient data. The patient application includes medication reminders, treatment process information, administration guidance, side effect management content, motivational messages, and an OPU countdown. The clinic panel enables secure monitoring of coded data such as medication adherence percentage, daily log-in frequency, module completion rates, and basic follow-up indicators.
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
- None
盲法说明
Because of the nature of the intervention, blinding of participants and study staff is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 years and older
- •Diagnosed with primary infertility
- •Scheduled to undergo oocyte pick-up (OPU) for the first time
- •Newly starting medication treatment during the period before OPU
- •Own a smartphone and are able to use basic mobile applications
- •Willing to participate in the study and provide written informed consent
排除标准
- •Diagnosis of secondary infertility
- •Presence of a serious chronic disease that may significantly affect medication adherence and/or quality of life
- •Presence of an active serious psychiatric disorder
- •Cognitive or physical limitation that prevents use of the mobile application
研究组 & 干预措施
Routine clinical care plus OPUCARE
Participants will receive routine clinical care and standard written and verbal information provided by the clinic, plus the OPUCARE system during the period before oocyte pick-up (OPU).
干预措施: OPUCARE (Behavioral)
Routine clinical care plus OPUCARE
Participants will receive routine clinical care and standard written and verbal information provided by the clinic, plus the OPUCARE system during the period before oocyte pick-up (OPU).
干预措施: Routine clinical care (Other)
Routine clinical care
Participants will receive routine clinical care and standard written and verbal information provided by the clinic during the period before oocyte pick-up (OPU), without mobile health application support.
干预措施: Routine clinical care (Other)
结局指标
主要结局
Change in medication adherence score
时间窗: Baseline and day 14
Medication adherence will be assessed using the Medication Adherence Report Scale. The scale consists of 5 items scored on a 5-point Likert scale. Total scores range from 5 to 25, with higher scores indicating better medication adherence. The change in score between baseline and day 14 will be evaluated.
Change in fertility-related quality of life score
时间窗: Baseline and day 14
Fertility-related quality of life will be assessed using the Fertility Quality of Life Questionnaire. The questionnaire evaluates the impact of infertility and fertility treatment on quality of life. Scores are transformed to a 0 to 100 scale, with higher scores indicating better fertility-related quality of life. The change in score between baseline and day 14 will be evaluated.
Change in medication adherence score
时间窗: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Medication adherence will be assessed using the Medication Adherence Report Scale. The scale consists of 5 items scored on a 5-point Likert scale. Total scores range from 5 to 25, with higher scores indicating better medication adherence. The change in score between baseline and the day before oocyte pick-up will be evaluated.
Change in fertility-related quality of life score
时间窗: Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline)
Fertility-related quality of life will be assessed using the Fertility Quality of Life Questionnaire. The questionnaire evaluates the impact of infertility and fertility treatment on quality of life. Scores are transformed to a 0 to 100 scale, with higher scores indicating better fertility-related quality of life. The change in score between baseline and the day before oocyte pick-up will be evaluated.
次要结局
- Change in state anxiety score(Baseline and day 14)
- Change in state anxiety score(Baseline and the day before oocyte pick-up (approximately 2 weeks after baseline))