Asthma Clinical Trial
— FACTORADAPTOfficial title:
Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.
Verified date | March 2024 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project consists of a psychological intervention in patients and their families with different chronic diseases in order to carry out a comparative study between medical pathologies to know which are the protective or risk variables for the adaptation to the disease.
Status | Completed |
Enrollment | 500 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 16 Years |
Eligibility | Inclusion Criteria: - Diagnosis at least 6 months. - To have signed the informed consent. Exclusion Criteria: - No previous psychological diagnosis. - Attention Deficit Hyperactivity Disorder(ADHD), epilepsy or brain tumor - Infant cerebral palsy - Not understanding the Spanish language |
Country | Name | City | State |
---|---|---|---|
Spain | University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia | Hospital Clínico Universitario de Valencia, Hospital General Universitario de Valencia, Hospital Universitario La Fe |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glycaemic control (Baseline-Pre-Post) | HbA1c: It will be used to evaluate the glycemic control of the diabetic patient in endocrinology diseases | Baseline up to 12 months | |
Other | Weight (Baseline-Pre-Post) | Kilograms For assessment of nutritional status | Baseline up to 12 months | |
Other | Height (Baseline-Pre-Post) | Meters For assessment of nutritional status | Baseline up to 12 months | |
Other | Body mass index (BMI) (Baseline-Pre-Post) | BMI in kg/m^2, for assessment of nutritional status | Baseline up to 12 months | |
Other | Spirometry values (Baseline-Pre-Post) | All values obtained are expressed as volume (in ml). The main spirometric parameters recorded are forced vital capacity (FVC), vital capacity (VC), peak expired air volume in the first second (FEV1) and peak expiratory flow (PEF). | Baseline up to 12 months | |
Other | Blood test ( Baseline-Pre-Post) | For monitoring nutritional status (blood concentration of protein, lipids, fat-soluble vitamins, iron and calcium-phosphorus metabolism) and blood concentration of c) glucose metabolism d) acute phase reactants and immune status (immunoglobulins, alpha1 antitrypsin, and e) hepatic and renal functions.) exocrine pancreatic function
• glucose metabolism d) acute phase reactants and immune status (immunoglobulins, alpha1 antitrypsine) |
Baseline up to 12 months | |
Other | Exocrine pancreatic test ( Baseline-Pre-Post) | For monitoring pancreatic test, faecal elastase and steatorrhoea, and hepatic and renal functions. | Baseline up to 12 months | |
Primary | Change Emotional Distress in caregivers (Baseline-Pre-Post) | Assessment with Hospital Anxiety and Depression Scale in caregivers (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The scale is made up of 14 items, with a range of scores from 0 to 42. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Primary | Change Emotional Distress in patients (Baseline-Pre-Post) | Assessment with Hospital Anxiety and Depression Scale in patients (HADS): Screening instrument for the detection of affective disorders, in non-psychiatric subjects who go to hospitals. The adaptation for this sample, it is made up of 11 items, with a range of scores from 0 to 33. The interpretation is that the higher the score, the greater the presence of anxiety-depressive symptoms.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Primary | Change Caregiver burden (Baseline-Pre-Post) | Assessment with Parental Inventory: It aims to assess the stress of parents with children who require regular medical attention. It consists of 12 situations related to the hospital environment that are considered potentially stressful for parents with sick children. The range of scores is 12 to 60. And it is interpreted like higher scores, higher levels of stress.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Primary | Change Emotional competences in patients (Baseline-Pre-post) | Emotional Skills and Competence Questionnaire (ESCQ-21): this is a self-report measure developed by Takšic to assess emotional competence. In the present study, the reduced version (ESCQ-21) was used, adapted and validated in a Spanish sample by Schoeps et al. The aim of assessing is emotional competence: perception and comprehension, expressing and labeling and management and regulation) | Baseline up to 12 months | |
Primary | Change Self-esteem in patients (Baseline-Pre-Post) | Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up | Baseline up to 12 months | |
Primary | Change of Perceived level of disease threat (Baseline-Pre-Post) | Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive | Baseline up to 12 months | |
Secondary | Change Resilience in caregivers (Baseline-Pre-Post) | Connor-Davidson Resilience Scale to assess the ability to cope with stress and adversity. The resilience scale is made up of 10 items, with a range of scores from 0 to 40, with higher scores indicating greater resilience.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Secondary | Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post) | Adaptive response questionnaire to the disease in diabetic patients: with the aim of evaluating the elements involved in the psychological and social response in pediatric diabetic patients. This instrument includes cognitive, emotional and behavioural elements that may be related to the adjustment response to the disease. The lower the score, the more severe the disease, the worse the health behaviour, the various complaints associated with the disease.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Secondary | Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post | This questionnaire evaluates health-related quality of life in relation to chronic respiratory problems. It is made up of 4 dimensions: sensation of dyspnea, sensation of fatigue, emotional symptomatology and disease control.
The total score is obtained by adding up the score in each of the dimensions and dividing by 4. The resulting evaluation ranges from 1 (maximum affectation of up to 7 (no affectation) First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Secondary | Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post) | It is a specific quality of life assessment instrument for the pediatric population with rhinoconjunctivitis. It aims to obtain a measure of the impact that allergic symptoms have on patients' daily functioning, and not only the severity and frequency. All items are weighted equally and a higher score is indicative of a poorer quality of life.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Secondary | Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post) | Quality of Life Questionnaire in Food Allergy (FAQLQ- TF) It assessed quality of life relation with food allergy. The range of scores is from 0 to 6. The interpretation of the scores is reversed, i.e. the lower the score, the better the perceived quality of life.
First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: PRE- Up to 6 months after the first measurement the second measurement of the same variable was carried out. Third measurement: POST Up to 6 months after the second measurement the third measurement of the same variable was carried out. |
Baseline up to 12 months | |
Secondary | Change in family functioning in caregivers (Baseline-Pre-Post) | Family Functioning Questionnaire (CAF) based on Olson's model. It was created with the aim of constructing a measuring instrument to evaluate the variables that make up the dynamics of a family | Baseline up to 12 months | |
Secondary | Change in parental styles in patients (Baseline-Pre-Post) | Scale for the evaluation of the educational style of parents of adolescents (EP). It allows evaluating the perception that adolescents have of the educational style of their parents. | Baseline up to 12 months | |
Secondary | Change Psychological well-being (Baseline-Pre-Post) | Psychological well-being scale for adolescents (BIEPS-J) to determine the level of psychological well-being in adolescents | Baseline up to 12 months |
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