Juvenile Idiopathic Arthritis
Conditions
Keywords
Sleep deficiency, self-management
Brief summary
Sleep deficiency is a public health concern in children with a chronic illness such as Juvenile Idiopathic Arthritis (JIA) because it is often overlooked in clinical care, attributed to the underlying chronic illness, and contributes to poor health outcomes. Development of an effective technology-based sleep shared-management intervention that integrate children and parents in the co-design and development of the intervention has the potential to improve health outcomes of children living with JIA and their parents.
Detailed description
To develop and test a technology-based sleep shared-management intervention delivered to 8-to-13 year-old children with JIA and their parents. The initial feasibility, acceptability, and efficacy of the newly developed sleep shared-management intervention will be tested in a pilot randomized controlled trial comparing the active intervention against standard care with a sample of 60 children with JIA and their parents. Sleep will be measured using actigraphy, sleep diaries, & self-report measures. Self-efficacy will be measured before and after the intervention. The long-term goal is to develop effective and low cost treatments to reduce sleep deficiency and the sleep-related health consequences among children with JIA. The specific aims are to: Aim 1. Apply a human-centered design approach to develop and refine a technology-based sleep shared-management intervention (SLEEPSMART). Direct stakeholder input will be obtained from children and parents about their needs for sleep shared-management as well as intervention material adapted from the Transdiagnostic Sleep-Circadian Dysfunction program for youth that includes four cross cutting components (sleep complaint, education, behavior change and motivation, and goal setting) across the modules and a shared- management focus (motivation, self-efficacy) with children and parent partnering together to improve sleep. Qualitative methods (iterative cycles of semi-structured audiotaped sessions with children and parents and think-aloud observation sessions by a trained observer) will be used to evaluate the usability of the SLEEPSMART prototype. Results of these analyses will guide program finalization. Aim 2. Determine feasibility and initial efficacy of the SLEEPSMART with children with JIA in a pilot RCT. Study accrual and dropout rates will be assessed, as well as, levels of patient acceptability and engagement in a pilot randomized controlled trial (RCT) comparing usual care to SLEEPSMART intervention. Preliminary effect sizes of the SLEEPSMART will be determined in youth receiving treatment compared to usual care on primary outcomes of actigraphy sleep duration, self-report sleep disturbances, and feasibility/acceptability, and secondary outcomes include self-efficacy.
Interventions
BEHAVIORALSLEEPSAMRT
SLEEPSMART is a web-based intervention that adapted and modified components from the Transdiagnostic Sleep and Circadian intervention for youth and included four cross-cutting components (sleep complaint, education, behavior change and motivation, and goal-setting) that were integrated into each module. To begin the intervention, participants were provided a link to the SLEEPSMART intervention website for one of the above modules and an online sleep coach each week. At the end of each week, children and parents uploaded the weekly activities and goals via the REDCap link and set up a meeting with the sleep coach to review. The modules took 20 to 30 minutes to complete.
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
for Children: * diagnosed with JIA, 8-13 years, and parent report that child has difficulties with sleep quality (difficulty falling asleep, no bedtime routine, waking up in the middle of the night and struggling to fall back asleep) and/or poor sleep impacts their child's day to day function (school, interacting with peers, hobbies). Inclusion criteria for parents: * \> 18 years, access to a computer or web-based device to complete the surveys, and residing with the child more than 50% of the time
Exclusion criteria
for Children: * Diagnosed with a sleep disorder (OSA), positive screen on the pediatric sleep questionnaire for OSA, lack of daily access to the internet, developmental delay, currently taking sleep medication (melatonin), and currently participating in psychological therapy and/or participated in psychological therapy the prior 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion) | PROMIS Sleep Disturbance an 8-item questionnaire that measures self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Items are rated on a 5-point Likert scale (1= not at all/very poor, 2 = a little bit/poor, 3=somewhat/fair, 4=quite a bit/good, 5= very much/very good). The raw scores are converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores suggest more disturbed sleep. |
| Sleep Efficiency | Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion) | Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep. |
| Sleep Duration | baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) | Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period; |
| Acceptability of SLEEPSMART | 3 months at study completion | Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments. Items are scored using a 5-point scale, with 1 equalling strongly disagree and 5 equalling strongly agree. Scores can range from 9 to 45 with higher scores representing greater acceptance. A total score of moderate acceptability for the nine items would be 27. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy Child | Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) | Self-Efficacy scale: 9-item self-report of confidence in carrying out sleep-related behaviors; Likert scale from 1 (not at all confident) to 10 (totally confident); higher score indicates better self-efficacy. |
| Self-efficacy Parent | baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion) | A 9-item survey that assesses parent confidence to manage/control their children's chronic conditions and sleep, emotional functioning, and communication with healthcare providers. Items are rated using a visual analog scale, ranging from 1 = not at all confident to 10 = totally confident. A mean score is calculated with higher values indicative of higher self-efficacy |
Countries
United States
Participant flow
Recruitment details
We recruited 50 children with JIA and 50 parents.
Pre-assignment details
The number of participants in each Milestone represents each child and each parent in the SLEEPSMART Intervention group and each child and each parent in the control group.
Participants by arm
| Arm | Count |
|---|---|
| SLEEPSMART PROGRAM Arm: Experimental group 24 children and 24 parents (n=48) that equates to 24 child/co-parent dyads | 48 |
| Placebo Comparator (Usual Care) Arm: Placebo Comparator (Usual care) represents 20 children and 20 parents (n=40) that equates to 20 child/co-parent dyads. This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. | 40 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| T2 Immediate Post-Intervention | did not respond | 5 | 3 |
| T2 Immediate Post-Intervention | Did not respond during intervention or usual care | 5 | 3 |
Baseline characteristics
| Characteristic | SLEEPSMART PROGRAM | Placebo Comparator (Usual Care) | Total |
|---|---|---|---|
| Age, Continuous Child | 10.1 years STANDARD_DEVIATION 1.7 | 10.5 years STANDARD_DEVIATION 1.8 | 10.3 years STANDARD_DEVIATION 1.7 |
| Age, Continuous Parent | 40.7 years STANDARD_DEVIATION 5.4 | 43.3 years STANDARD_DEVIATION 6 | 41.95 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Child Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Child Not Hispanic or Latino | 20 Participants | 14 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Child Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 20 Participants | 15 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Child Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Child White | 20 Participants | 17 Participants | 37 Participants |
| Race (NIH/OMB) Parent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent White | 21 Participants | 17 Participants | 38 Participants |
| Sex: Female, Male Child Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Child Male | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Parent Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Parent Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 21 |
| other Total, other adverse events | 0 / 25 | 0 / 21 |
| serious Total, serious adverse events | 0 / 25 | 0 / 21 |
Outcome results
Primary
Acceptability of SLEEPSMART
Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments. Items are scored using a 5-point scale, with 1 equalling strongly disagree and 5 equalling strongly agree. Scores can range from 9 to 45 with higher scores representing greater acceptance. A total score of moderate acceptability for the nine items would be 27.
Time frame: 3 months at study completion
Population: At 2 months and 3 months, some participants declined to participate or could not be reached.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SLEEPSMART PROGRAM | Acceptability of SLEEPSMART | 34.1 score on a scale | Standard Deviation 8.2 |
| Placebo Comparator (Usual Care) | Acceptability of SLEEPSMART | 36.6 score on a scale | Standard Deviation 6.4 |
Primary
Sleep Disturbance
PROMIS Sleep Disturbance an 8-item questionnaire that measures self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Items are rated on a 5-point Likert scale (1= not at all/very poor, 2 = a little bit/poor, 3=somewhat/fair, 4=quite a bit/good, 5= very much/very good). The raw scores are converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores suggest more disturbed sleep.
Time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
Population: At 2 and 3 months, some participants could not be reached or declined to participate.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEPSMART PROGRAM | Sleep Disturbance | Baseline | 62.1 T-score | Standard Deviation 5.4 |
| SLEEPSMART PROGRAM | Sleep Disturbance | 2 months | 57.7 T-score | Standard Deviation 4.3 |
| SLEEPSMART PROGRAM | Sleep Disturbance | 3 months | 56.4 T-score | Standard Deviation 2.8 |
| Placebo Comparator (Usual Care) | Sleep Disturbance | Baseline | 62.4 T-score | Standard Deviation 7.3 |
| Placebo Comparator (Usual Care) | Sleep Disturbance | 2 months | 58.3 T-score | Standard Deviation 7.6 |
| Placebo Comparator (Usual Care) | Sleep Disturbance | 3 months | 58.5 T-score | Standard Deviation 7.1 |
Primary
Sleep Duration
Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period;
Time frame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEPSMART PROGRAM | Sleep Duration | Baseline | 464.0 minutes | Standard Deviation 46.7 |
| SLEEPSMART PROGRAM | Sleep Duration | 2 months | 508.6 minutes | Standard Deviation 57.4 |
| SLEEPSMART PROGRAM | Sleep Duration | 3 months | 506.7 minutes | Standard Deviation 48.1 |
| Placebo Comparator (Usual Care) | Sleep Duration | 2 months | 483.6 minutes | Standard Deviation 28.1 |
| Placebo Comparator (Usual Care) | Sleep Duration | Baseline | 483.2 minutes | Standard Deviation 25.1 |
| Placebo Comparator (Usual Care) | Sleep Duration | 3 months | 488.7 minutes | Standard Deviation 33.4 |
Primary
Sleep Efficiency
Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep.
Time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
Population: At 2 months and 3 months, some participants declined to participate or could not be reached.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEPSMART PROGRAM | Sleep Efficiency | Baseline | .74 ratio | Standard Deviation 0.08 |
| SLEEPSMART PROGRAM | Sleep Efficiency | 2 months | .83 ratio | Standard Deviation 0.05 |
| SLEEPSMART PROGRAM | Sleep Efficiency | 3 months | .84 ratio | Standard Deviation 0.07 |
| Placebo Comparator (Usual Care) | Sleep Efficiency | Baseline | .78 ratio | Standard Deviation 0.05 |
| Placebo Comparator (Usual Care) | Sleep Efficiency | 2 months | .79 ratio | Standard Deviation 0.04 |
| Placebo Comparator (Usual Care) | Sleep Efficiency | 3 months | .79 ratio | Standard Deviation 0.04 |
Secondary
Self-efficacy Child
Self-Efficacy scale: 9-item self-report of confidence in carrying out sleep-related behaviors; Likert scale from 1 (not at all confident) to 10 (totally confident); higher score indicates better self-efficacy.
Time frame: Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Population: At 2 months and 3 months, subjects (3 Placebo and 5 SLEEPSMART Intervention) declined to participate or could not be reached.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEPSMART PROGRAM | Self-efficacy Child | Baseline | 2.5 score on a scale | Standard Deviation 0.8 |
| SLEEPSMART PROGRAM | Self-efficacy Child | 2 Months | 2.0 score on a scale | Standard Deviation 0.6 |
| SLEEPSMART PROGRAM | Self-efficacy Child | 3 Months | 2.0 score on a scale | Standard Deviation 0.8 |
| Placebo Comparator (Usual Care) | Self-efficacy Child | Baseline | 2.4 score on a scale | Standard Deviation 2.8 |
| Placebo Comparator (Usual Care) | Self-efficacy Child | 2 Months | 2.3 score on a scale | Standard Deviation 0.8 |
| Placebo Comparator (Usual Care) | Self-efficacy Child | 3 Months | 2.2 score on a scale | Standard Deviation 0.9 |
Secondary
Self-efficacy Parent
A 9-item survey that assesses parent confidence to manage/control their children's chronic conditions and sleep, emotional functioning, and communication with healthcare providers. Items are rated using a visual analog scale, ranging from 1 = not at all confident to 10 = totally confident. A mean score is calculated with higher values indicative of higher self-efficacy
Time frame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Population: At 2 months and 3 months, some particpants declined to participate or could not be reached.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEPSMART PROGRAM | Self-efficacy Parent | 3 months | 7.5 score on a scale | Standard Deviation 1.4 |
| SLEEPSMART PROGRAM | Self-efficacy Parent | Baseline | 5.8 score on a scale | Standard Deviation 1.9 |
| SLEEPSMART PROGRAM | Self-efficacy Parent | 2 months | 7.1 score on a scale | Standard Deviation 1.3 |
| Placebo Comparator (Usual Care) | Self-efficacy Parent | Baseline | 6.5 score on a scale | Standard Deviation 1.6 |
| Placebo Comparator (Usual Care) | Self-efficacy Parent | 2 months | 6.6 score on a scale | Standard Deviation 1.9 |
| Placebo Comparator (Usual Care) | Self-efficacy Parent | 3 months | 7.2 score on a scale | Standard Deviation 1.9 |