Down Syndrome
Conditions
Keywords
Online Health Tool, Health evaluations, Celiac Screen, Sleep Study, Thyroid Test, Audiogram, Ophthalmology evaluation, Healthcare outcomes survey, Experience survey
Brief summary
The investigators conducted a national two-arm, randomized controlled trial of caregivers of individuals with DS to assess the efficacy of DSC2U in assuring adherence to evidence-based guidelines. The research plan was approved by the Partners Human Research Committee.
Detailed description
Background: The overwhelming majority of people with Down syndrome do not have access to specialty clinics, a disparity resulting in delayed or missed diagnoses and significant untreated co-morbidities. To meet this critical gap in needs, the investigators created Down Syndrome Clinic to You (DSC2U), a novel, web-based tool created for caregivers of individuals with Down syndrome, which generates personalized recommendations for the caregiver and the patient's primary care provider (PCP). Methods: In a national, randomized controlled trial of 230 caregivers who had children or dependents with Down syndrome without access to a Down syndrome specialist, 117 were randomized to receive DSC2U and 113 to receive usual-care. The primary outcome was adherence to five health evaluations indicated by national guidelines for Down syndrome: celiac screen, sleep study, thyroid test, audiogram, and ophthalmology evaluation.
Interventions
OTHERDown Syndrome Clinic to You (DSC2U)
DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome.
Sponsors
Patient-Centered Outcomes Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Potential eligible participants were directed to the study website (www.dsc2u.org) for the eligibility screening questionnaire in English and Spanish and online consent. After selecting a language preference (English or Spanish), in addition to questions about the child's or dependent's biological sex, race and ethnicity, the eligibility screening questions included: 1. Do you have a child or dependent with DS? 2. Is your child or dependent 1 year or older? 3. When is your child's next annual well visit (PCP visit)? 4. Does your child or dependent currently receive care at a DS specialty clinic? (If the child or dependent was actively followed in a DS specialty clinic, even one out of state. For example, a family from Arizona who travels to Texas each year for their child to be seen in a DS specialty clinic would be ineligible) Inclusion Criteria: * If you have a child or dependent with Down syndrome (DS) * If your child or dependent is 1 year or older * If your child or dependent is does not receive care at a DS specialty clinic
Exclusion criteria
* If your child or dependent does receive care at a DS specialty clinic * If your child or dependent is under 1 year old * If your child or dependent has a PCP that is already involved in the study DS occurs naturally and proportionally in all races and ethnicities, so the study's population estimates were proportional to the racial/ethnic distribution of the U.S. population, as reported in the 2010 U.S. Census. To achieve commensurate representation in the study, the investigators applied a quota system in offering enrollment using the race and ethnicity of the individual with DS (not the caregiver). The investigators' plan was to enroll participants such that there were: no more than 144 white individuals with DS, no fewer than 25 Hispanic or Latino/Latina individuals with DS, and no fewer than 20 black individuals with DS. The team also planned to enroll no more than 120 individuals with DS of one sex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 7 months after the participant's scheduled PCP visit | Adherence to the five health evaluations indicated by national guidelines for Down syndrome. The five health evaluations included: celiac screen, sleep study, thyroid test, audiogram, and ophthalmology evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire: Caregiver Experience With the Intervention | 2 weeks and 7 months after their scheduled PCP visit and with the intervention | Measure the caregiver experience with the PCP using a 10-point Likert scale with 10 representing most helpful and 0 representing least helpful. This questionnaire was only distributed to those in the Intervention arm because it assessed their experience with the Intervention itself. |
| Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | Change from baseline at the 2-week follow-up time point | PedsQL 4.0 parent-proxy and PedsQL 2.0 Family Impact Module (https://www.pedsql.org/) were used to assess for qualify of life for people with Down syndrome and their caregivers. Here we report the change from baseline on the subdomains of these assessments. The subdomains on PedsQL 4.0 parent proxy were Psychosocial and Physical. The subdomains on the Family Impact Module (FIM) were Parental and Family scores. For both instruments we also report the total/summary scores. PedsQL scoring instructions were used. These are all scaled from 0 (Low) to 100 (High). Higher scores indicate a better quality of life. Baseline: (Mean±SD); Change: (Mean±SE) |
| Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | 7-month follow-up survey | PedsQL 4.0 parent-proxy and PedsQL 2.0 Family Impact Module (https://www.pedsql.org/) were used to assess for qualify of life for people with Down syndrome and their caregivers. Here we report the change from baseline on the subdomains of these assessments. The subdomains on PedsQL 4.0 parent proxy were Psychosocial and Physical. The subdomains on the Family Impact Module (FIM) were Parental and Family scores. For both instruments we also report the total/summary scores. PedsQL scoring instructions were used. These are all scaled from 0 (Low) to 100 (High). Higher scores indicate a better quality of life. Baseline: (Mean±SD); Change: (Mean±SE) |
| PCP Experience With the Intervention (Down Syndrome Clinic to You) | 2 weeks after the scheduled PCP visit | These measurements were gathered by self-administered mail survey to the PCPs who had patients participating in the Intervention Group. A total of 94 PCPs who had patients in the Intervention Arm responded to this question: Did \[name\]'s caregiver give you a copy of the primary care plan before and/or during the wellness visit? (Note: this survey was not mailed to the PCPs who had patients participating in the Control group as the survey was a measure of experience with the Intervention itself.) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through online social media postings from MassGeneral Hospital and Down syndrome (DS) non-profit organizations around the U.S. The recruitment period started on October 3, 2017 and end on September 30, 2018. Additional recruitment measures were implemented to enroll a demographically diverse sample. These included contacting minority working groups of DS organizations and translated all recruitment materials in Spanish.
Pre-assignment details
We assessed 645 caregivers for eligibility through the study website, and 281 were consented. After consent, there were 51 consented caregivers who were excluded from the study prior to randomization because they did not complete the baseline survey, changed their primary care provider visit to a date outside of the study window, or self-withdrew. As such, 230 caregivers were randomized into assignment groups.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group The participants randomized to the intervention group completed the DSC2U questionnaire, and received online access to a personalized Caregiver Checklist and PCP plan. Caregivers were encouraged to share and discuss the PCP plan at their next wellness visit with the PCPs.
Down Syndrome Clinic to You (DSC2U): DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome. | 117 |
| Control Group The participants randomized to the control group, received usual care for 7 months, after their scheduled PCP appointment. They did not receive DSC2U during these 7 months, but did receive the online, personalized health assessment tool (DSC2U) at the end of the 7 months, after the primary and secondary outcomes were measured. | 113 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 2-week Follow-up Survey for Caregivers | Lost to Follow-up | 5 | 0 |
| 2-week Follow-up Survey for Caregivers | Not responsive | 7 | 5 |
| 2-week Follow-up Survey for PCP's | Not responsive | 20 | 25 |
| 7-month Follow-up Survey for Caregivers | Lost to Follow-up | 11 | 3 |
| Primary Care Provider (PCP) Visit | Did not complete PCP visit | 2 | 0 |
| Randomization | Discontinued participation because uncomfortable sharing information | 1 | 0 |
| Randomization | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Customized 13 to 17 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Customized 18 to 25 years | 13 Participants | 11 Participants | 24 Participants |
| Age, Customized 26 years or older | 12 Participants | 15 Participants | 27 Participants |
| Age, Customized 2 to 4 years | 29 Participants | 28 Participants | 57 Participants |
| Age, Customized < 2 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Customized 5 to 7 years | 17 Participants | 16 Participants | 33 Participants |
| Age, Customized 8 to 12 years | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 13 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 98 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Primary health care insurance None (e.g. self-pay) | 1 Number of participants | 1 Number of participants | 2 Number of participants |
| Primary health care insurance Private (e.g. Blue Cross) | 84 Number of participants | 83 Number of participants | 167 Number of participants |
| Primary health care insurance Public (e.g. Medicaid) | 32 Number of participants | 29 Number of participants | 61 Number of participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 101 Participants | 100 Participants | 201 Participants |
| Sex: Female, Male Female | 54 Participants | 52 Participants | 106 Participants |
| Sex: Female, Male Male | 63 Participants | 61 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 117 | 0 / 113 |
| other Total, other adverse events | 0 / 117 | 0 / 113 |
| serious Total, serious adverse events | 0 / 117 | 0 / 113 |
Outcome results
Primary
Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP
Adherence to the five health evaluations indicated by national guidelines for Down syndrome. The five health evaluations included: celiac screen, sleep study, thyroid test, audiogram, and ophthalmology evaluation.
Time frame: 7 months after the participant's scheduled PCP visit
Population: People with Down syndrome
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 0 indicated evaluations recommend/complete | 69 participants |
| Intervention Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 1 indicated evaluations recommend/complete | 36 participants |
| Intervention Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 2 indicated evaluations recommend/complete | 10 participants |
| Intervention Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 3 indicated evaluations recommend/complete | 2 participants |
| Control Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 3 indicated evaluations recommend/complete | 0 participants |
| Control Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 0 indicated evaluations recommend/complete | 79 participants |
| Control Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 2 indicated evaluations recommend/complete | 3 participants |
| Control Group | Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP | 1 indicated evaluations recommend/complete | 31 participants |
p-value: 0.018Cochran-Armitage trend test
Secondary
PCP Experience With the Intervention (Down Syndrome Clinic to You)
These measurements were gathered by self-administered mail survey to the PCPs who had patients participating in the Intervention Group. A total of 94 PCPs who had patients in the Intervention Arm responded to this question: Did \[name\]'s caregiver give you a copy of the primary care plan before and/or during the wellness visit? (Note: this survey was not mailed to the PCPs who had patients participating in the Control group as the survey was a measure of experience with the Intervention itself.)
Time frame: 2 weeks after the scheduled PCP visit
Population: PCPs who had patients in the Intervention Arm responded to this question: Did \[name\]'s caregiver give you a copy of the primary care plan before and/or during the wellness visit?
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | PCP Experience With the Intervention (Down Syndrome Clinic to You) | Yes, before the visit | 11 Participants |
| Intervention Group | PCP Experience With the Intervention (Down Syndrome Clinic to You) | missing | 3 Participants |
| Intervention Group | PCP Experience With the Intervention (Down Syndrome Clinic to You) | No | 55 Participants |
| Intervention Group | PCP Experience With the Intervention (Down Syndrome Clinic to You) | Yes, at the visit | 25 Participants |
Secondary
Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up
PedsQL 4.0 parent-proxy and PedsQL 2.0 Family Impact Module (https://www.pedsql.org/) were used to assess for qualify of life for people with Down syndrome and their caregivers. Here we report the change from baseline on the subdomains of these assessments. The subdomains on PedsQL 4.0 parent proxy were Psychosocial and Physical. The subdomains on the Family Impact Module (FIM) were Parental and Family scores. For both instruments we also report the total/summary scores. PedsQL scoring instructions were used. These are all scaled from 0 (Low) to 100 (High). Higher scores indicate a better quality of life. Baseline: (Mean±SD); Change: (Mean±SE)
Time frame: Change from baseline at the 2-week follow-up time point
Population: participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change from baseline score at 2 weeks on PedsQL Total Scale Score | -2.0 score on a scale | Standard Deviation 1.1 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | Change from baseline at 2 weeks on PedsQL Psychosocial Health Score | -3.2 score on a scale | Standard Deviation 1 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score for PedsQL FIM Parental | 68.6 score on a scale | Standard Deviation 18.2 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change from baseline score at 2 weeks on PedsQL Physical Functioning Score | -0.2 score on a scale | Standard Deviation 1.9 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change in baseline score at 2 weeks on PedsQL FIM Parental HRQL Summary Score | -2.4 score on a scale | Standard Deviation 1.3 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL Psychosocial Health Score | 69.8 score on a scale | Standard Deviation 14.7 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL FIM Family | 66.2 score on a scale | Standard Deviation 20.7 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL Total Scale | 67.7 score on a scale | Standard Deviation 13.6 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change in baseline score at 2 weeks for PedsQL FIM Family Functioning Summary Score | -0.8 score on a scale | Standard Deviation 1.5 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score for PedsQL FIM Total Scale Score | 65.8 score on a scale | Standard Deviation 17.6 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change in baseline score for PedsQL FIM Total Scale Score | -0.7 score on a scale | Standard Deviation 1.1 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL Physical | 63.4 score on a scale | Standard Deviation 25.4 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change in baseline score for PedsQL FIM Total Scale Score | -1.8 score on a scale | Standard Deviation 1.1 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score for PedsQL FIM Total Scale Score | 64.9 score on a scale | Standard Deviation 20.3 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL Psychosocial Health Score | 71.2 score on a scale | Standard Deviation 13.3 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | Change from baseline at 2 weeks on PedsQL Psychosocial Health Score | -2.3 score on a scale | Standard Deviation 0.9 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL Physical | 62.9 score on a scale | Standard Deviation 28.6 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change from baseline score at 2 weeks on PedsQL Physical Functioning Score | -0.8 score on a scale | Standard Deviation 1.9 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL Total Scale | 68.4 score on a scale | Standard Deviation 15.5 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change from baseline score at 2 weeks on PedsQL Total Scale Score | -1.6 score on a scale | Standard Deviation 1 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score for PedsQL FIM Parental | 67.4 score on a scale | Standard Deviation 19.6 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change in baseline score at 2 weeks on PedsQL FIM Parental HRQL Summary Score | -2.3 score on a scale | Standard Deviation 1.2 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | baseline score on PedsQL FIM Family | 65.2 score on a scale | Standard Deviation 24.6 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 2-week Follow-up | change in baseline score at 2 weeks for PedsQL FIM Family Functioning Summary Score | -1.8 score on a scale | Standard Deviation 1.5 |
Comparison: This is the p value for the PedsQL Psychosocial Health Scorep-value: 0.468ANOVA
Comparison: This p value is for the PedsQL Physical Functioning Scorep-value: 0.802ANOVA
Comparison: This is the p value for the PedsQL Total Scale Scorep-value: 0.761ANOVA
Comparison: This is the p value for the PedsQL FIM Parental HRQL Summary Scorep-value: 0.965ANOVA
Comparison: This is the p value for the PedsQL FIM Family Functioning Summary Scorep-value: 0.619ANOVA
Comparison: This is the p value for the PedsQL FIM Total Scale Scorep-value: 0.469ANOVA
Secondary
Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up
PedsQL 4.0 parent-proxy and PedsQL 2.0 Family Impact Module (https://www.pedsql.org/) were used to assess for qualify of life for people with Down syndrome and their caregivers. Here we report the change from baseline on the subdomains of these assessments. The subdomains on PedsQL 4.0 parent proxy were Psychosocial and Physical. The subdomains on the Family Impact Module (FIM) were Parental and Family scores. For both instruments we also report the total/summary scores. PedsQL scoring instructions were used. These are all scaled from 0 (Low) to 100 (High). Higher scores indicate a better quality of life. Baseline: (Mean±SD); Change: (Mean±SE)
Time frame: 7-month follow-up survey
Population: Participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL FIM Parental HRQL Summary Score | 68.6 scores on scales | Standard Deviation 18.2 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL Psychosocial Health Score | -2.3 scores on scales | Standard Deviation 1.1 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL FIM Parental HRQL Summary Score | -4.0 scores on scales | Standard Deviation 1.3 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL Physical Functioning Score | 6.0 scores on scales | Standard Deviation 1.9 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL FIM Family Functioning Summary Score | 66.2 scores on scales | Standard Deviation 20.7 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL | 69.8 scores on scales | Standard Deviation 14.7 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL FIM Family Functioning Summary Score | -2.0 scores on scales | Standard Deviation 1.4 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL Total | 67.7 scores on scales | Standard Deviation 13.6 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL FIM Total Scale Score | 65.8 scores on scales | Standard Deviation 17.6 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL Total Scale Score | 0.6 scores on scales | Standard Deviation 1.1 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL FIM Total Scale Score | -2.3 scores on scales | Standard Deviation 1.1 |
| Intervention Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL Physical Functioning Score | 63.4 scores on scales | Standard Deviation 25.4 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL FIM Total Scale Score | -0.4 scores on scales | Standard Deviation 1.1 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL | 71.2 scores on scales | Standard Deviation 13.3 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL Psychosocial Health Score | 0.4 scores on scales | Standard Deviation 1.1 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL Physical Functioning Score | 62.9 scores on scales | Standard Deviation 28.6 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL Physical Functioning Score | 6.3 scores on scales | Standard Deviation 2.5 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL Total Scale Score | 2.5 scores on scales | Standard Deviation 1.1 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL FIM Parental HRQL Summary Score | 67.4 scores on scales | Standard Deviation 19.6 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL FIM Parental HRQL Summary Score | -1.2 scores on scales | Standard Deviation 1.3 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL FIM Family Functioning Summary Score | 65.2 scores on scales | Standard Deviation 24.6 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | Change from baseline for PedsQL FIM Family Functioning Summary Score | 0.3 scores on scales | Standard Deviation 1.4 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL FIM Total Scale Score | 64.9 scores on scales | Standard Deviation 20.3 |
| Control Group | Quality of Life Outcomes for Person With Down Syndrome: 7-month Follow-up | baseline for PedsQL Total | 68.4 scores on scales | Standard Deviation 15.5 |
Comparison: This is for the change from baseline on PedsQL Psychosocial Health Scorep-value: 0.068ANOVA
Comparison: This is for the change from baseline for PedsQL Physical Functioning Scorep-value: 0.907ANOVA
Comparison: This is for the change from baseline for PedsQL Total Scale Scorep-value: 0.196ANOVA
Comparison: This is for the change from baseline for PedsQL FIM Parental HRQL Summary Scorep-value: 0.112ANOVA
Comparison: This is for change from baseline for PedsQL FIM Family Functioning Summary Scorep-value: 0.245ANOVA
Comparison: This is for change from baseline for PedsQL FIM Total Scale Scorep-value: 0.219ANOVA
Secondary
Questionnaire: Caregiver Experience With the Intervention
Measure the caregiver experience with the PCP using a 10-point Likert scale with 10 representing most helpful and 0 representing least helpful. This questionnaire was only distributed to those in the Intervention arm because it assessed their experience with the Intervention itself.
Time frame: 2 weeks and 7 months after their scheduled PCP visit and with the intervention
Population: Of note, the number of analyzed in 7-month follow-up differs from number of analyzed in 2-week follow-up because certain questions were included at the 2-week follow-up survey which were not included in the 7-month follow-up survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did the caregiver checklist explain the recommendations in a way that was easy for you to understand | No | 3 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you use the links to information that were included in the Caregiver Checklist? | Yes, somewhat | 39 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you have any problems viewing, downloading, or printing the Caregiver Checklist? | No | 91 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you use the links to information that were included in the Caregiver Checklist? | Yes, definitely | 38 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did the caregiver checklist explain the recommendations in a way that was easy for you to understand | Yes, somewhat | 11 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you discuss the Caregiver Checklist or any of the recommendations with the [name]? | No | 58 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you have any problems viewing, downloading, or printing the Caregiver Checklist? | Yes, definitely | 5 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you discuss the Caregiver Checklist or any of the recommendations with the [name]? | Yes, somewhat | 19 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did the caregiver checklist explain the recommendations in a way that was easy for you to understand | Yes, definitely | 87 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Would you recommend the Caregiver Checklist to another caregiver? | No | 0 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you have any problems viewing, downloading, or printing the Caregiver Checklist? | Yes, somewhat | 5 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Would you recommend the Caregiver Checklist to another caregiver? | Yes, somewhat | 17 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you use the links to information that were included in the Caregiver Checklist? | No | 24 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Would you recommend the Caregiver Checklist to another caregiver? | Yes, definitely | 84 Participants |
| Intervention Group | Questionnaire: Caregiver Experience With the Intervention | Did you discuss the Caregiver Checklist or any of the recommendations with the [name]? | Yes, definitely | 24 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Would you recommend the Caregiver Checklist to another caregiver? | Yes, definitely | 76 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you discuss the Caregiver Checklist or any of the recommendations with the [name]? | Yes, definitely | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you have any problems viewing, downloading, or printing the Caregiver Checklist? | No | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you have any problems viewing, downloading, or printing the Caregiver Checklist? | Yes, somewhat | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you have any problems viewing, downloading, or printing the Caregiver Checklist? | Yes, definitely | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did the caregiver checklist explain the recommendations in a way that was easy for you to understand | No | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did the caregiver checklist explain the recommendations in a way that was easy for you to understand | Yes, somewhat | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did the caregiver checklist explain the recommendations in a way that was easy for you to understand | Yes, definitely | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you use the links to information that were included in the Caregiver Checklist? | No | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you use the links to information that were included in the Caregiver Checklist? | Yes, somewhat | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you use the links to information that were included in the Caregiver Checklist? | Yes, definitely | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you discuss the Caregiver Checklist or any of the recommendations with the [name]? | No | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Did you discuss the Caregiver Checklist or any of the recommendations with the [name]? | Yes, somewhat | 0 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Would you recommend the Caregiver Checklist to another caregiver? | No | 1 Participants |
| Control Group | Questionnaire: Caregiver Experience With the Intervention | Would you recommend the Caregiver Checklist to another caregiver? | Yes, somewhat | 26 Participants |