Trial Outcomes & Findings for The Psychosocial Outcomes in Caregivers of Children With Food Allergy (NCT NCT04512924)

NCT ID: NCT04512924

Last Updated: 2025-08-11

Results Overview

The PROMISED Interference (Short Form 6a) instrument measures the self-reported consequences of fatigue across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher t-scores indicate greater pain interference. Higher scores represent greater degrees of fatigue. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe fatigue. Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-08-11

Participant Flow

Participant milestones

Measure	Group 1 Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Overall Study STARTED	10	20
Overall Study COMPLETED	10	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Psychosocial Outcomes in Caregivers of Children With Food Allergy

Baseline characteristics by cohort

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years n=5 Participants	32.3 years n=7 Participants	33.1 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The PROMISED Interference (Short Form 6a) instrument measures the self-reported consequences of fatigue across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher t-scores indicate greater pain interference. Higher scores represent greater degrees of fatigue. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue. Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form: PROMIS Short Form 6a	50.6 score on a scale Interval 43.3 to 57.8	53 score on a scale Interval 48.5 to 57.4

PRIMARY outcome

Timeframe: 4 months

The Patient-Reported Outcomes Measurement Information System Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue. Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form. PROMIS Short Form 6a	52.2 score on a scale Interval 48.1 to 56.3	49.5 score on a scale Interval 46.1 to 53.0

PRIMARY outcome

Timeframe: 30 days

Change in mean sleep disturbance score measured with PROMIS Sleep Disturbance short form 6a, 6 individual items allow for different responses which are scored separately to provide specific information about self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or the greater the individual's sleep is disturbed compared to individuals with chronic conditions. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe sleep disturbance.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Sleep Disturbance as Assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. PROMIS Sleep Disturbance Short Form 6a	59.9 score on a scale Interval 58.0 to 61.8	58.8 score on a scale Interval 57.0 to 60.6

PRIMARY outcome

Timeframe: 4 months

The Patient-Reported Outcomes Measurement Information System Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. A low score indicates low sleep disturbance; high score indicates high sleep disturbance. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe." Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the T score for the average quality of sleep in the reference general population, with a standard deviation of 10. Higher T scores reflect greater sleep disturbance, and thus worse outcomes. The means reported are the mean T scores at the indicated timepoint.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Sleep Disturbance as Assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. PROMIS Sleep Disturbance Short Form 76a	59.3 score on a scale Interval 57.1 to 61.5	59.7 score on a scale Interval 58.0 to 61.4

PRIMARY outcome

Timeframe: 30 days

The Patient-Reported Outcomes Measurement Information System Depression item banks assess self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate negative mood; lower scores indicate more positive mode. Six items are rated on a 5 point scale that assess caregiver depression; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate greater severity in depression. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe." T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Depression as Assessed by Patient-Reported Outcomes Measurement Information System Depression Short Form. PROMIS Depression Short Form 6a	43.6 T-score Interval 37.6 to 49.6	45.9 T-score Interval 42.2 to 49.6

PRIMARY outcome

Timeframe: 4 months

The Patient-Reported Outcomes Measurement Information System Depression item banks assess self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate negative mood; lower scores indicate more positive mode. Six items are rated on a 5 point scale that assess caregiver depression; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate greater severity in depression. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe." T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Depression as Assessed by Patient-Reported Outcomes Measurement Information System Depression Short Form. PROMIS Depression Short Form 6a	44.1 T-score Interval 39.5 to 48.7	45.6 T-score Interval 41.2 to 50.0

PRIMARY outcome

Timeframe: 30 days

The Patient-Reported Outcomes Measurement Information System Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The anxiety measure is universal rather than disease-specific. Higher scores indicate higher levels of anxiety; lower scores indicate lower levels of anxiety. Six items are rated on a 5 point scale that assess caregiver anxiety; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate a greater severity in anxiety. Scores less than 55 are "within normal limits", 55-60 are "mild", 60-70 are "moderate", and greater than 70 are "severe". The raw score is converted to a T-score ranging from 31.7 to 76.1. 50 indicates the population mean with a standard deviation of 10. Higher T-scores indicate greater anxiety disturbance.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Anxiety as Assessed by Patient-Reported Outcomes Measurement Information System Anxiety Short Form. PROMIS Anxiety Short Form 6a	51.2 T-score Interval 42.8 to 59.5	55.1 T-score Interval 50.0 to 60.3

PRIMARY outcome

Timeframe: 4 months

The Patient-Reported Outcomes Measurement Information System Anxiety item assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness) . The anxiety measure is universal rather than disease-specific. Higher scores indicate higher levels of anxiety; lower scores indicate lower levels of anxiety. Six items are rated on a 5 point scale that assess caregiver anxiety; 1=Never to 5=Always. To find the total raw score, sum the values of the response to each question. Higher scores indicate a greater severity in anxiety. Scores less than 55 are "within normal limits", 55-60 are "mild", 60-70 are "moderate", and greater than 70 are "severe". The raw score is converted to a T-score ranging from 31.7 to 76.1, 50 indicates the population mean with a standard deviation of 10 Higher T-scores indicate greater anxiety disturbance.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Anxiety as Assessed by Patient-Reported Outcomes Measurement Information System Anxiety Short Form. PROMIS Anxiety Short Form 6a	51.2 T-score Interval 44.7 to 57.6	52.3 T-score Interval 47.8 to 56.8

PRIMARY outcome

Timeframe: 30 days

Food Allergy Self Efficacy Scale for Parents (FASE-P) The FASE-P measures parental confidence in their ability to manage their child's FA. Subdomains include managing social activities, precaution and prevention, allergic treatment, food allergen identification, and seeking information about FA. Each item is rated from 0-100 and a mean score is calculated. Higher scores indicate greater FA-related self-efficacy. The FASE-P offers excellent reliability over time in a general FA population.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Caregiver Self-efficacy Related to Managing Food Allergy in Child as Assessed by the Food Allergy Self-Efficacy Scale for Parents:(FASE-P): Treat my Child if They Had an Allergic Reaction	78.7 score on a scale Interval 61.8 to 95.6	87.2 score on a scale Interval 78.2 to 96.2

PRIMARY outcome

Timeframe: 4 months

Food Allergy Self Efficacy Scale for Parents (FASE-P) The FASE-P measures parental confidence in their ability to manage their child's FA. Subdomains include managing social activities, precaution and prevention, allergic treatment, food allergen identification, and seeking information about FA. Each item is rated from 0-100 and a mean score is calculated. Higher scores indicate greater FA-related self-efficacy. The FASE-P offers excellent reliability over time in a general FA population.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Caregiver Self-efficacy Related to Managing Food Allergy in Child as Assessed by the Food Allergy Self-Efficacy Scale for Parents (FASE-P):Treat my Child if They Had an Allergic Reaction	86.5 score on a scale Interval 74.9 to 98.1	92.6 score on a scale Interval 87.5 to 97.8

PRIMARY outcome

Timeframe: Baseline and 30 days

The FAQL-PB is a 17-item questionnaire designed to capture caregiver HRQoL in children ages 0-12 years with FA. Items are rated on a 7-point Likert scale (0=not limited/troubled to 6=extremely limited/troubled); a mean score is calculated with higher scores indicating poorer HRQoL.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Change in Caregiver Quality of Life-parental Burden as Assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB): How Limited Would Your Ability to Participate in Social Activities That Involve Food be Because of Your Child's Food Allergy?	2.9 score on a scale Interval 1.8 to 4.0	2.8 score on a scale Interval 2.0 to 3.6

PRIMARY outcome

Timeframe: Baseline and 4 months

The FAQL-PB is a 17-item questionnaire designed to capture caregiver HRQoL in children ages 0-12 years with FA. Items are rated on a 7-point Likert scale (0=not limited/troubled to 6=extremely limited/troubled); a mean score is calculated with higher scores indicating poorer HRQoL.

Outcome measures

Measure	Group 1 n=10 Participants Enhanced mobile app with standard of care and education: Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.	Group 2 n=20 Participants Enhanced mobile app with standard of care, education and support resources: Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
Change in Caregiver Quality of Life-parental Burden as Assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB):How Limited Would Your Ability to Participate in Social Activities That Involve Food be Because of Your Child's Food Allergy?	2.3 score on a scale Interval 1.2 to 3.4	1.7 score on a scale Interval 1.0 to 2.3

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brantlee Broome

Medical University of South Carolina

Phone: 843-792-3370

Email: broomeb@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place