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临床试验/NCT07434570
NCT07434570已完成不适用

Evaluating the Effectiveness of Video-based Apps in Healthcare

University of Calgary1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年12月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Activities-specific Balance Confidence (ABC) Scale

研究概览

简要总结

The goal of this clinical trial is to understand the effectiveness of a novel video-feedback based mobile application that teaches walking aid skills to current or anticipated walking aid users. The main questions it aims to answer are:

  1. Does this app improve balance confidence in walking aid users, as compared to a sham app?
  2. Does this app improve clinically relevant outcomes in walking aid users, as compared to a sham app?

Researchers will compare balance confidence and clinical outcomes to a control group undergoing the same protocol but using an identical app that teaches teaching general health skills instead. The intervention group will be learning the skills of fitting and walking with their gait aid while the control group will be learning the skills of deep breathing to reduce stress and turning in bed safely.

Participants will take part in 3 data collection sessions. The first two, that will be about 4-6 days apart, are identical. During these two data sessions, the participants will begin by completing a pre-app survey, then completing 2 app modules, and finish by completing a post-app survey. About 26-30 days after the second study visit, participants will be asked to complete a survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
6 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 6 and 99
  • Currently using a walker, crutch(es), or cane(s) ≥ 5 days/week, OR will be expecting to use such a walking aid for ≥ 7 days in a row (for those undergoing planned surgery)

排除标准

  • Self-identify as being unable to comfortably communicate in English
  • Self-identify as having a significant visual impairment that would affect their ability to use an app that involves watching videos
  • Self-identify as using a wheelchair, walking poles, or a knee scooter for ≥ 75% of the time for mobility

研究组 & 干预措施

Intervention Group

Experimental

Participants will use a video feedback-based app to learn how to correctly fit and walk with their usual gait aid.

干预措施: Walking Aid Skills App (Device)

Control Group

Sham Comparator

Participants will use an attentional control app (same interface as the interventional app) to learn how to breathe deeply to reduce stress and how to turn in bed safely from back-to-side.

干预措施: Attentional Control (Device)

结局指标

主要结局

Activities-specific Balance Confidence (ABC) Scale

时间窗: Will be obtained during data collection for all 3 timepoints (T1: baseline, T2: T1 + 4-6 days, T3: T1 + 26-30 days).

The ABC is a 16-item self-reported questionnaire. Items involve tasks that may challenge balance. For each item, the individual rates their confidence in performing the task without losing their balance from 0% (not confident) to 100% (completely confident). The total score ranges from 0% (not confident) to 100% (completely confident). Higher scores mean a better outcome.

次要结局

  • Objective knowledge: Multiple-choice knowledge test(At all 3 data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Self-reported confidence in 4 skill domains (walking aid fitting, assisted gait with a walking aid, deep breathing for stress relief, and safely turning in bed)(At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Self-reported knowledge in 4 skill domains (walking aid fitting, assisted gait with a walking aid, deep breathing for stress relief, and safely turning in bed)(At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Self-reported comfort with 4 skill domains (walking aid fitting, assisted gait with a walking aid, deep breathing for stress relief, and safely turning in bed)(At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Upper limb pain: Numerical Pain Rating Scale (NPRS)(At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days))
  • Lower limb pain: Numerical Pain Rating Scale (NPRS)(At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days))
  • Description of Skin Issues(At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Number of Falls(At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • System Usability Scale (SUS)(During data collection periods involving app use (T1: Baseline; T2: T1 + 4-6 days).)

研究者

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

Ranita Manocha

Clinical Associate Professor

University of Calgary

研究点 (1)

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