Evaluation of a New Bladder Health Mobile Application in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire
研究概览
简要总结
Millions of women experience involuntary loss of urine called urinary incontinence (UI). UI can be slightly bothersome or totally debilitating. Women experience UI twice as often as men. Urinary incontinence can also be a persistent condition caused by underlying physical problems or changes, including pregnancy and childbirth. UI symptom severity progress dynamically and are also sustained over time. High quality evidence shows that pelvic floor muscle training (PFMT) during pregnancy effectively reduces the risk of UI during pregnancy and the postpartum period. There is a critical need for a low cost and easily accessible program to prevent UI in pregnancy and postpartum that can reach a large number of women. A mobile health application that teaches UI preventive program during pregnancy has the potential of being a cost effective tool to reach a large number of pregnant women. The Bladder Health Mobile Application (BHmApp) will teach pregnant women new habits and exercises that will keep their bladder healthy during pregnancy and decrease the risk of UI during this period of a woman's life that is considered high risk for developing UI. In this pilot study, it is proposed to evaluate the understand and effectively use the BHmApp, and the feasibility of using the BHmApp during pregnancy.
详细描述
Urinary incontinence (UI) is the involuntary and unintentional leaking of urine. Over 20 million of women experience UI, approximately 34% (range 25-45%) of all US women are affected indicating a significant healthcare concern with both financial and quality of life implications. The financial cost of UI in the United States (U.S) exceeds $65 billion per year (in year 2007 dollars), and it is projected that the cost will be $82.6 billion in 2020.Women with UI feel shame about this condition, report poor self-esteem, and are at increased risk of depression. Pregnancy is a high-risk time for developing stress UI, urine leakage with physical effort, with a reported prevalence of 35-67% during pregnancy and 31% postpartum. Pregnancy also places women at increased risk of developing UI later in life.
High quality evidence shows that pelvic floor muscle training (PFMT) during pregnancy effectively reduces the risk of UI during pregnancy and the postpartum period by 39-59%. A recent Cochrane review examined the evidence for PFMT based on 38 trials involving 9,892 women from 20 countries. The authors concluded that in continent pregnant women, performing antenatal PFMT may decrease the risk of UI in late pregnancy and in the mid-postnatal period greater 3 to six months postpartum. However, evidence shows that many women in the U.S. do not receive effective PFMT. PFMT to prevent UI is not routinely offered or well taught to pregnant women.
There is a critical need for a low cost and easily accessible program to prevent UI in pregnancy and postpartum that can reach a large number of women. Such a program could reduce the financial and psychological impact of UI on pregnant women, lower the risk of UI with its associated negative outcomes and address a priority area identified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). A mobile health application that teaches UI preventive program during pregnancy has the potential of being a cost effective tool to reach a large number of pregnant women. The plan is to offer PFMT, the Knack (squeeze before you sneeze trick), bladder training (BT) with urge suppression and healthy bladder education (fluid modification, bowel habits) using a mobile health application that allows women to learn and practice these new habits anytime and anywhere that is convenient to them. In the pilot studies, as supported by other studies, it was learned that the main obstacles to preventing UI by means of PFMT are the feasibility of group classes and low adherence to the exercise routine. Mobile health application (mApp) offers an innovative approach to improve feasibility. PFMT mApps showed effectiveness in women with stress UI and improved adherence to PFMT in women with UI. Additionally, stress UI self-management that includes PFMT with mApp has been shown to be cost-effective. Measurement of adherence to behavioral protocols has often been overlooked in research. Few studies provide information about how adherent women were with PFMT and the literature is sparse on methods to identify barriers and improve adherence. Adherence to PFM exercises during pregnancy was reported to be between 16%-69%, and adherence rates 4-6 weeks after delivery were 43%-83%. Common reasons for not doing PFMT during pregnancy and postpartum include exercises are: forgetting, being too busy, and the belief they have become unnecessary due to the absence of symptoms. Using a mobile App is an innovative way to address these obstacles. To help women overcome these particular barriers, this study proposes a Bladder Health mobile application (BHmApp) that will use various forms of reminders, provide exercise aids, link daily exercises to environmental cues, and integrate exercises into the patient's everyday activities.
To support adherence, the BHmAPP will communicate realistic expectations, make it clear that it may take weeks to months for symptom improvement, and it may be irregular, with "good" days and "bad" days. The BHmApp can provide support by tracking and reinforcing progress, identifying and addressing barriers, and encouraging persistence.
During the last year, the team worked on designing and building the BHmApp aimed to teach pregnant women new habits and exercises that will keep their bladder healthy during pregnancy and decrease the risk of UI during this period of a woman's life that is considered high risk for developing UI. In this pilot study, it is proposed to evaluate the ability to comprehend the tool and take appropriate actions using the BHmApp, and the feasibility of using the BHmApp during pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women age 18 years or older at 10-18 weeks gestation
- •Ability to understand English
- •Negative history or no more than 5 episodes of UI in the past 12 months
- •Negative history of neuromuscular or genitourinary conditions
- •Low-risk antepartum
- •Singleton pregnancy
- •Owner of a smart phone
排除标准
- •High-risk pregnancy, including medical complications during pregnancy, such as preterm delivery, preterm premature rupture of membranes, diabetes, or hypertensive disorders and history of prior diagnosis or treatment (behavioral, drug or surgical) for urinary incontinence
结局指标
主要结局
Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire
时间窗: 4 weeks after enrollment
Percentage of positive responses to understandability questions (1-19) of the PMAT survey, where each question has a score of 0=disagree and 1=agree for each question. The sum of total points is divided by the sum of total possible points and multiplied by 100 to get percentage. A high score indicates the participant understood the material well.
Actionability score from Patient Education Materials Assessment Tool (PMAT) questionnaire
时间窗: 4 weeks after enrollment
Percentage of positive responses to actionability questions (20-26) of the PMAT survey, where each question has a score of 0=disagree and 1=agree for each question. The sum of total points is divided by the sum of total possible points and multiplied by 100 to get percentage. A high score indicates the participant was able to develop an action plan from the material.
次要结局
- Recruitment Success(At enrollment)
- Retention rate(12 weeks postpartum)
- Data completion rate(12 weeks post partum)
- Urinary Incontinence (UI) rate - baseline(at enrollment)
- Urinary Incontinence (UI) rate - 34-36 weeks gestation(34-36 weeks gestation)
- Urinary Incontinence (UI) rate - 6 weeks postpartum(6 weeks post partum)
- Urinary Incontinence (UI) rate - 12 weeks postpartum(12 weeks post partum)
- Adherence to Pelvic Floor Muscle Training (PFMT) - 26-28 weeks gestation(26-28 weeks gestation)
- Adherence to Pelvic Floor Muscle Training (PFMT) - 30-32 weeks gestation(30-32 weeks gestation)
- Adherence to Pelvic Floor Muscle Training (PFMT) - 34-36 weeks gestation(34-36 weeks gestation)
- Adherence to Pelvic Floor Muscle Training (PFMT) - 6 weeks postpartum(6 weeks postpartum)
- Adherence to Pelvic Floor Muscle Training (PFMT) - 12 weeks postpartum(12 weeks postpartum)
- Bladder Training Adherence - 6 weeks postpartum(6 weeks post partum)
- Bladder Training Adherence - 12 weeks postpartum(12 weeks post partum)
- Voiding interval - 6 weeks postpartum(6 weeks post partum)
- Voiding interval - 12 weeks postpartum(12 weeks post partum)
- Barriers to Use of bladder training - 6 weeks postpartum(6 weeks post partum)
- Barriers to Use of bladder training - 12 weeks postpartum(12 weeks post partum)
研究者
Elie Mulhem
Vice Chair, Department of Family Medicine and Community Health
Corewell Health East
