Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431425
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-08
Brief Title:
The Electronic Cardiovascular Genetics eCG Clinic for Presymptomatic Genetic Counselling
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
The Electronic Cardiovascular Genetics eCG Clinic for Presymptomatic Genetic Counselling Evaluation of Uptake Psychological Impact and Satisfaction Among Users
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eCG
Brief Summary:
Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern When a mutation is detected in the proband relatives can have predictive DNA testing and - when they are carrier - be monitored and timely treated if needed Currently less than half of relatives attends genetic counselling With the eCG Family Clinic an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered At the eCG Family Clinic relatives will receive tailored information to support informed decision-making a DNA-test at home if desired and can be referred for local cardiac monitoring if relatives appear to be a carrier Implementation of the eCG Family Clinic in clinical practice is compared to current practice in this clinical trial
Detailed Description:
Background
Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern When a mutation is detected in the proband relatives can have predictive DNA testing and - when they are carrier - be monitored and timely treated if needed Currently less than half of relatives attends genetic counselling With the eCG Family Clinic an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered At the eCG Family Clinic relatives will receive tailored information to support informed decision-making a DNA-test at home if desired and can be referred for local cardiac monitoring if relatives appear to be a carrier Implementation of the eCG Family Clinic in clinical practice intervention group is compared to current practice control group in this clinical trial
Hypotheses
It is hypothesized that the eCG Family Clinic can lower practical barriers for at-risk relatives to attend genetic counselling and equally or better suit the needs of probands and relatives in this regard A higher uptake of presymptomatic counselling in the eCG Family Clinic intervention group is expected
Design
A non-inferiority randomised controlled trial RCT design with two study arms parallel-group control- and intervention group for this study was chosen In this study probands at-risk relatives and genetic healthcare professionals will be recruited for this study The Medical Ethical Committee of the University Medical Centre Utrecht UMCU NedMec has approved the study design
Measures
In this RCT the following outcome measures will be evaluated 1 uptake of presymptomatic counselling among at-risk relatives 2 satisfaction with provided care among healthcare professionals probands and at-risk relatives 3 impact on feelings of anxiety and worry among at-risk relatives 4 time requested for care provision and administration Uptake of presymptomatic testing will be evaluated using file research Data on the other outcome measures will be collected using questionnaires First probands will be asked to fill out one questionnaire after informing at-risk relatives In addition at-risk relatives are asked to fill out a questionnaire twice a shortly after the presymptomatic counselling time-point 1 and b after twothree months in which at-risk relatives who chose to have DNA-testing will have received their results Finally healthcare professionals involved in providing counselling will be asked to fill out one questionnaire after study completion Questionnaires will also be used to administer sociodemographic and clinical characteristics of study participants
Sample size calculation
Assuming a two-sided 5 significance level and a power of 80 238 at-risk relatives 119 per study arm will be included Previous literature shows that on average four adult relatives per proband are at 50 risk of inheriting the genetic mutation Using a conservative estimate of 35 relatives per proband a total of 68 probands 34 per study arm needs to be included in this study
Statistical analyses
Sociodemographic and clinical characteristics will be analysed using descriptive and frequency statistics Differences in participant characteristics between study arms will assessed with chi-square tests t-tests as appropriate Differences in uptake of genetic counselling will be analysed using chi-square tests logistic regression analyses will be conducted to assess differences in uptake while controlling for the influence of coviarates Multilevel analyses will be performed to assess whether the study group has an impact on satisfaction with the care provided and impact on psychological functioning adjusted for coviarates SPSS version 2901 will be used to perform statistical analyses A p-level of p005 will be used
Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern When a mutation is detected in the proband relatives can have predictive DNA testing and - when they are carrier - be monitored and timely treated if needed Currently less than half of relatives attends genetic counselling With the eCG Family Clinic an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered At the eCG Family Clinic relatives will receive tailored information to support informed decision-making a DNA-test at home if desired and can be referred for local cardiac monitoring if relatives appear to be a carrier Implementation of the eCG Family Clinic in clinical practice intervention group is compared to current practice control group in this clinical trial
Hypotheses
It is hypothesized that the eCG Family Clinic can lower practical barriers for at-risk relatives to attend genetic counselling and equally or better suit the needs of probands and relatives in this regard A higher uptake of presymptomatic counselling in the eCG Family Clinic intervention group is expected
Design
A non-inferiority randomised controlled trial RCT design with two study arms parallel-group control- and intervention group for this study was chosen In this study probands at-risk relatives and genetic healthcare professionals will be recruited for this study The Medical Ethical Committee of the University Medical Centre Utrecht UMCU NedMec has approved the study design
Measures
In this RCT the following outcome measures will be evaluated 1 uptake of presymptomatic counselling among at-risk relatives 2 satisfaction with provided care among healthcare professionals probands and at-risk relatives 3 impact on feelings of anxiety and worry among at-risk relatives 4 time requested for care provision and administration Uptake of presymptomatic testing will be evaluated using file research Data on the other outcome measures will be collected using questionnaires First probands will be asked to fill out one questionnaire after informing at-risk relatives In addition at-risk relatives are asked to fill out a questionnaire twice a shortly after the presymptomatic counselling time-point 1 and b after twothree months in which at-risk relatives who chose to have DNA-testing will have received their results Finally healthcare professionals involved in providing counselling will be asked to fill out one questionnaire after study completion Questionnaires will also be used to administer sociodemographic and clinical characteristics of study participants
Sample size calculation
Assuming a two-sided 5 significance level and a power of 80 238 at-risk relatives 119 per study arm will be included Previous literature shows that on average four adult relatives per proband are at 50 risk of inheriting the genetic mutation Using a conservative estimate of 35 relatives per proband a total of 68 probands 34 per study arm needs to be included in this study
Statistical analyses
Sociodemographic and clinical characteristics will be analysed using descriptive and frequency statistics Differences in participant characteristics between study arms will assessed with chi-square tests t-tests as appropriate Differences in uptake of genetic counselling will be analysed using chi-square tests logistic regression analyses will be conducted to assess differences in uptake while controlling for the influence of coviarates Multilevel analyses will be performed to assess whether the study group has an impact on satisfaction with the care provided and impact on psychological functioning adjusted for coviarates SPSS version 2901 will be used to perform statistical analyses A p-level of p005 will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None