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Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood
The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration.
There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention.
Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease.
Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life.
The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.
| Condition or disease | Intervention/treatment |
|---|---|
| Congenital Heart Disease | Other: Questionnaire |
| Study Type : | Observational |
| Actual Enrollment : | 118 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood |
| Actual Study Start Date : | April 1, 2018 |
| Actual Primary Completion Date : | July 15, 2019 |
| Actual Study Completion Date : | July 15, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Congenital Heart Disease
Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.
|
Other: Questionnaire
Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.
|
- Quality of life assessment [ Time Frame: 30 minutes ]Quality of life will be assessed by means of a questionnaire adapted to adult patients suffering from congenital cardiopathy and having had surgery during childhood. There are 76 short closed questions, about 6 different domains (physical activity, social life, family life, professional life, scholarity, psychological comfort).
- Medical antecedents [ Time Frame: 30 minutes ]List of medical antecedents of the patient
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- congenital heart disease,
- patients having had surgery during childhood,
- patients followed within the CHU Brugmann Hospital.
Exclusion Criteria:
- None.
| Belgium | |
| CHU Brugmann | |
| Brussels, Belgium, 1020 | |
| Principal Investigator: | Marine DENEUBOURG, MD | CHU Brugmann |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | February 8, 2018 | ||||
| First Posted Date | April 17, 2019 | ||||
| Last Update Posted Date | July 16, 2019 | ||||
| Actual Study Start Date | April 1, 2018 | ||||
| Actual Primary Completion Date | July 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Quality of life assessment [ Time Frame: 30 minutes ] Quality of life will be assessed by means of a questionnaire adapted to adult patients suffering from congenital cardiopathy and having had surgery during childhood. There are 76 short closed questions, about 6 different domains (physical activity, social life, family life, professional life, scholarity, psychological comfort).
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Medical antecedents [ Time Frame: 30 minutes ] List of medical antecedents of the patient
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood | ||||
| Official Title | Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood | ||||
| Brief Summary |
The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration. There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention. Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease. Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life. The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adults suffering from congenital heart disease, having had surgery during childhood, followed within the CHU Brugmann Hospital. | ||||
| Condition | Congenital Heart Disease | ||||
| Intervention | Other: Questionnaire
Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.
|
||||
| Study Groups/Cohorts | Congenital Heart Disease
Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.
Intervention: Other: Questionnaire
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
118 | ||||
| Original Estimated Enrollment |
200 | ||||
| Actual Study Completion Date | July 15, 2019 | ||||
| Actual Primary Completion Date | July 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03917706 | ||||
| Other Study ID Numbers | CHUB-congenital cardiopathy | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Pierre Wauthy, Brugmann University Hospital | ||||
| Study Sponsor | Pierre Wauthy | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Brugmann University Hospital | ||||
| Verification Date | July 2019 | ||||
