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临床试验/NCT06242717
NCT06242717招募中不适用

Postpartum Screening for Anxiety and Comorbid Conditions: A Prospective British Columbia Cohort Study

University of British Columbia1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2023年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
550
试验地点
1
主要终点
Percentage of participants who completed surveys

研究概览

简要总结

The goal of this project is to facilitate the design of individualized postpartum anxiety (PPA) screening strategies in British Columbia (BC), Canada. A cohort of postpartum people (n=550) will be invited to complete the following seven questionnaires at 4-8 weeks after delivery:

  1. State-Trait Anxiety Inventory
  2. Edinburgh Postnatal Depression Scale
  3. Multidimensional Scale of Perceived Social Support
  4. PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a
  5. Short Form Brief Pain Inventory
  6. WHOQOL-BREF for assessing quality of life
  7. PROMIS Sleep Disturbance Short Form 8-b and PROMIS Sleep-Related Impairment Short Form 8-a

The investigators will evaluate the feasibility of screening for postpartum anxiety and comorbid conditions through a web-based platform in a diverse BC population. They will assess the usability of the platform and questionnaires through 12-15 follow-up interviews with study participants and responses to the System Usability Scale. Their analysis will also identify patient characteristics and comorbidities (e.g., anger, pain, sleep disturbance) associated with a positive screen for postpartum anxiety.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ 19 years
  • 4-8 weeks postpartum
  • Proficiency to participate in English
  • Delivered within the province of British Columbia, Canada

排除标准

  • 未提供

结局指标

主要结局

Percentage of participants who completed surveys

时间窗: 4-8 weeks postpartum

The overall completion rate will be estimated as those completing (defined as \>70% completion rate) the entire screening divided by those recruited and will be provided with a corresponding 95% confidence interval.

Proportion of participants who consider usability of online surveys as being excellent (>85) with a System Usability Scale (SUS)

时间窗: 4-8 weeks postpartum

Feasibility will be determined by study completion rates and usability will be determined by SUS / b) SUS items have a range of 0-4. SUS scores range from 0 to 100 providing an estimate of overall usability of the intervention. Scores above 70 are considered to be acceptable or good while scores of 85 or above indicate a high level of usability or excellent score. Scores of 50 or below indicate poor or unacceptable usability. SUS scores and time to completion will be summarized based on above thresholds.

次要结局

  • Number of participants with high postpartum-related anxiety and/or poor sleep quality as assessed by validated questionnaires.(4-8 weeks postpartum)
  • Number of participants with high postpartum-related anxiety and/or high levels of pain as assessed by validated questionnaires.(4-8 weeks postpartum)
  • Number of participants with two or more comorbid comorbidities as described on outcome measures 4 to 9.(4-8 weeks postpartum)
  • Number of participants with high postpartum-related anxiety and/or high risk for depression as assessed by validated questionnaires.(4-8 weeks postpartum)
  • Number of participants with postpartum-related anxiety as assessed by the State-Trait Anxiety Inventory (STAI-S) and related predictors.(4-8 weeks postpartum)
  • Number of participants with high postpartum-related anxiety and/or low social support as assessed by validated questionnaires.(4-8 weeks postpartum)
  • Number of participants with high postpartum-related anxiety and/or low quality of life as assessed by validated questionnaires.(4-8 weeks postpartum)
  • Number of participants with high postpartum-related anxiety and/or high anger levels as assessed by validated questionnaires.(4-8 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne Vidler

Principle Investigator

University of British Columbia

研究点 (1)

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