Trial Outcomes & Findings for Communicating Health Information and Improving Coordination With Primary Care (NCT NCT03104543)
NCT ID: NCT03104543
Last Updated: 2024-03-06
Results Overview
Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
COMPLETED
NA
347 participants
1 year
2024-03-06
Participant Flow
Participant milestones
| Measure |
Education
Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months
|
Test Results
Test results only; with delayed access to the experimental materials
Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
172
|
|
Overall Study
COMPLETED
|
126
|
138
|
|
Overall Study
NOT COMPLETED
|
49
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Communicating Health Information and Improving Coordination With Primary Care
Baseline characteristics by cohort
| Measure |
Education
n=175 Participants
Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months
|
Test Results
n=172 Participants
Test results only; with delayed access to the experimental materials
Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
146 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other race/ethnicity
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Undertreated hypertension
|
68 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Undertreated dyslipidemia
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Undertreated diabetes
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Analysis population includes only those with 12 month follow-up data
Assess the overall probability of having any undertreated condition based on home visit measurements and blood testing
Outcome measures
| Measure |
Education
n=126 Participants
Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months
|
Test Results
n=138 Participants
Test results only; with delayed access to the experimental materials
Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
|
|---|---|---|
|
Undertreatment of Hypertension (>=140/90 mmHg), Dyslipidemia (LDL >=160 mg/dL or Triglyceride >=150 mg/dL), and/or Glucose Intolerance (if Prediabetes, Hemoglobin A1c >=5.7% or Fasting Glucose >=100; if Diabetes, Hemoglobin A1c >=7%)
Number of participants with undertreated hypertension at follow-up
|
49 participants
|
59 participants
|
|
Undertreatment of Hypertension (>=140/90 mmHg), Dyslipidemia (LDL >=160 mg/dL or Triglyceride >=150 mg/dL), and/or Glucose Intolerance (if Prediabetes, Hemoglobin A1c >=5.7% or Fasting Glucose >=100; if Diabetes, Hemoglobin A1c >=7%)
Number of participants with undertreated dyslipidemia at follow-up
|
43 participants
|
41 participants
|
|
Undertreatment of Hypertension (>=140/90 mmHg), Dyslipidemia (LDL >=160 mg/dL or Triglyceride >=150 mg/dL), and/or Glucose Intolerance (if Prediabetes, Hemoglobin A1c >=5.7% or Fasting Glucose >=100; if Diabetes, Hemoglobin A1c >=7%)
Number of participants with undertreated prediabeties / diabetes at follow-up
|
48 participants
|
54 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Analysis population includes only those with 12 month follow-up data
Childhood cancer survivors' self-reported health knowledge (measured by questionnaire)
Outcome measures
| Measure |
Education
n=126 Participants
Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months
|
Test Results
n=138 Participants
Test results only; with delayed access to the experimental materials
Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
|
|---|---|---|
|
Health Knowledge
Number participants who recalled prior anthracycline exposure correctly at follow-up
|
51 Participants
|
49 Participants
|
|
Health Knowledge
Number participants who recalled prior radiotherapy exposure correctly at follow-up
|
105 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Analysis population includes only those with 12 month follow-up data
Childhood cancer survivors' self-efficacy towards managing their healthcare (measured by questionnaire). Scale is based on work by: "Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in Health Psychology: A User's Portfolio. Casual and Control Beliefs. Windsor, UK:NFER-NELSON; 1995. p. 35-7." Specifically, the study used an adapted version of this scale with 5-items (4-point Likert scale) that measure perceived ability to set-goals, cope and recover from setbacks. The mean raw score for each participant was multiplied by 10 and converted to a T-score per survey developers' documentation, with 50 representing the US adult population mean, with a standard deviation of 10, and higher scores reflecting higher self-efficacy.
Outcome measures
| Measure |
Education
n=126 Participants
Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months
|
Test Results
n=138 Participants
Test results only; with delayed access to the experimental materials
Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
|
|---|---|---|
|
Self-efficacy
|
49.5 T-score
Standard Deviation 11.8
|
50.5 T-score
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Number of primary care providers
Healthcare providers' health knowledge and self-efficacy related to the care of childhood cancer survivors (measured by questionnaire). Specific question assesses providers' self-perceived skill in taking care of such survivors, rated from 1 (strongly disagree) to 5 (strongly agree).
Outcome measures
| Measure |
Education
n=77 Participants
Educational materials
Education: 30 minute education session; 15 minute booster session at 4 months
|
Test Results
n=79 Participants
Test results only; with delayed access to the experimental materials
Test results only: The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
|
|---|---|---|
|
Primary Care Provider Attitudes
|
3.37 units on a scale
Standard Deviation 1.23
|
3.46 units on a scale
Standard Deviation 1.13
|
Adverse Events
Education
Test Results
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place