Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials of Light Therapy for Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean System Usability Score (SUS).
研究概览
简要总结
This Personalized Trial will test the feasibility and effectiveness of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified fatigue. Participant's initial levels of fatigue and other outcomes will be assessed in a baseline period 2 weeks in length. Participants will spend 12 weeks alternating between bright light therapy, dim light therapy, and usual care methods to treat their fatigue, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about the Personalized Trials platform. The investigators believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.
详细描述
This Personalized Trial will test the feasibility of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified fatigue. Symptoms of fatigue will be defined using the PROMIS Fatigue measures. Following a 2 week baseline assessment period, participants will be randomized in a multiple crossover design to receive bright blue light therapy, dim blue light therapy, and usual care in 6 treatment periods 2 weeks in length (12 weeks total). Participants will be randomly assigned to 2 groups receiving treatments in different order. Group 1 will receive treatments in the following order: bright light, dim light, usual care, usual care, dim light, bright light. Group 2 will receive treatments in the following order: usual care, dim light, bright light, bright light, dim light, usual care. Light therapy will be delivered using commercial available devices manufactured by AYO. The total duration of the study will be 14 weeks. During the baseline assessments and all treatment periods, participants will be assessed using daily survey measures, weekly survey measures, ecological momentary assessment (EMA) measures delivered via text message 3 times daily, and information collected via a Fitbit device. Survey measures will assess participant self-reported fatigue. EMA measures will ask participants to rate their fatigue, pain, concentration, confidence, mood, and stress in the moment. Participant daily steps and nightly sleep duration will be assessed using the Fitbit Charge 3™ device. After at the end of the study, participants will receive a personalized report summarizing their data from the baseline assessment and from each treatment period. Participants will be asked to evaluate their experience with the Personalized N-of-1 Trial overall and each element of the trial using the System Usability Scale (SUS) as well as a satisfaction survey measure. Participant adherence to study intervention devices (e.g. AYO bright blue light and AYO dim blue light machines), survey measures, EMA measures, and Fitbit device usage will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean System Usability Score (SUS).
时间窗: Assessed once after the results report has been sent to the participant, within 4 months of intervention completion.
The SUS is a validated 10-item questionnaire that asks users to score each item on a Likert scale from Strongly Disagree (rating of 1) to Strongly Agree (rating of 5). The SUS will be presented to the participant as addressing the ease of use, complexity, consistency of the Personalized Trials system as a whole, from recruitment to receipt of the report. Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together and an overall mean will be reported with standard deviation. Higher scored values correlate to a more usable system, and therefore a better outcome.
次要结局
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.(EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Within-Subject Difference in Self-reported Weekly Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 8a.(Weekly fatigue will be assessed weekly via survey during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each).)
- Within-Subject Difference in Fitbit Device-Recorded Sleep Duration.(Nightly sleep duration will be assessed consistently via Fitbit Charge 3™ device during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.(Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.)
- Participant Satisfaction With Personalized Trial Components.(Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.(EMA concentration will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Within-Subject Difference in Fitbit Device-Recorded Daily Steps.(Daily steps will be assessed consistently via Fitbit Charge 3™ device during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Within-Subject Difference in Self-reported Daily Fatigue Assessed Using the PROMIS Item Bank v1.0 Fatigue 7b Daily(Daily fatigue will be assessed daily via survey during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.(EMA pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.(EMA confidence will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.(EMA mood will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.(EMA stress will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 treatment periods (2 weeks each, 12 weeks total).)
- Mean Participant Adherence to AYO Bright Blue Light Device.(Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.)
- Mean Participant Survey Adherence Rate.(Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.)
- Mean Fitbit Device Adherence Rate.(Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.)
- Mean Participant Adherence to AYO Dim Blue Light Device.(Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.)