Feasibility of Light Therapy for Fatigue N-of-1 Trials

Not Applicable

Completed

Conditions: Fatigue

Interventions: Device: Bright Blue Light Commercial AYO Light Therapy Device
Device: Dim Blue Light Commercial AYO Light Therapy Device

Registration Number: NCT04707846

Lead Sponsor: Northwell Health

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bright Light Therapy	Bright Blue Light Commercial AYO Light Therapy Device	Individuals will receive bright blue light therapy using glasses developed by AYO. During treatment blocks for bright blue light therapy, participants will receive a text message within an hour of their self-reported wake time instructing them to use their designated light therapy device for 30 minutes. Bright blue light therapy will be administered in 2 treatment periods each 2 weeks in length (4 weeks total). Bright blue light treatment has been previously identified as an efficacious treatment for fatigue. It has also been shown in a number of studies that the blue wavelength of light is a key component to the shift of fatigue measures in patient reported outcomes.
Dim Light Therapy	Dim Blue Light Commercial AYO Light Therapy Device	Individuals will receive dim blue light therapy using glasses developed by AYO. During treatment blocks for bright blue light therapy, participants will receive a text message within an hour of their self-reported wake time instructing them to use their designated light therapy device for 30 minutes. Dim blue light therapy will be administered in 2 treatment periods each 2 weeks in length (4 weeks total).

Primary Outcome Measures

Name	Time	Method
Mean System Usability Score (SUS).	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.

Secondary Outcome Measures

Name	Time	Method
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).	Fatigue will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their fatigue on a scale of 0(low) to 10(high). Levels of EMA fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA fatigue will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA fatigue over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	All Weekly Fatigue items are rated on a scale of 1 to 5, with higher scores indicating higher levels of fatigue. PROMIS Weekly Fatigue scale scores will be converted to T-scores using methods from the PROMIS scoring manual based on item response theory. Levels of weekly fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of weekly fatigue will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in weekly fatigue over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	Nightly sleep duration will be assessed by a Fitbit Charge 3™ device. Sleep duration will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean sleep duration will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Sleep duration values over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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.	For each participant of the proportion of EMA measures completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.
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.	Participants will rate their satisfaction with the Personalized N-of-1 Trial overall and with individual elements of the trial in a satisfaction survey administered following the baseline and treatment periods (14 weeks). Satisfaction items are not part of an already existing scale but were developed to assess participant satisfaction with specific elements of the current study and the personalized trial overall. Participants will rate their satisfaction on a scale of 1 to 5, with higher numbers indicating greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.
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).	Concentration will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their concentration on a scale of 0(low) to 10(high). Levels of EMA concentration will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA concentration will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA concentration over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	Daily step counts will be assessed by a Fitbit Charge 3™ device. Daily step counts will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean daily steps will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Daily steps values over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	All Daily Fatigue items are rated on a scale of 1 to 5, with higher scores indicating higher levels of fatigue. PROMIS Daily Fatigue scale scores will be converted to T-scores using methods from the PROMIS scoring manual based on item response theory. Levels of daily fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of fatigue will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in daily fatigue over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	Pain will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their pain on a scale of 0(low) to 10(high). Levels of EMA pain will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA pain will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA pain over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	Confidence will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their confidence on a scale of 0(low) to 10(high). Levels of EMA confidence will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA confidence will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA confidence over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	Mood will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their mood on a scale of 0(poor) to 10(excellent). Levels of EMA mood will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA mood will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA mood over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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).	Stress will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their stress on a scale of 0(low) to 10(high). Levels of EMA stress will be aggregated within the baseline assessment period and in each of the treatment periods (bright light, dim light, and usual care) to generate an overall mean and standard deviation for each period. Mean levels of EMA stress will be compared to baseline using three paired-samples t-tests (bright light vs baseline, dim light vs baseline, usual care vs baseline). Changes in EMA stress over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.
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.	For each participant, the proportion of days where 30-minute sessions using the bright blue light device were completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Mean Participant Survey Adherence Rate.	Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.	For each participant of the proportion of surveys measures completed (both daily and weekly surveys) will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Mean Fitbit Device Adherence Rate.	Assessed once after the results report has been sent to the participant, within 12 weeks of the study period.	For each participant, the proportion of days where the Fitbit device was worn will be calculated. Completion rates across all participants will be reported with means and standard deviations.
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.	For each participant, the proportion of days where 30-minute sessions using the dim blue light device were completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.