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Trial record 2 of 3 for:    VIDA asthma

Intervention in Chronic Pediatric Patients and Their Families. (FACTORADAPT)

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ClinicalTrials.gov Identifier: NCT04476433
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborators:
Hospital General Universitario de Valencia
Hospital Clínico Universitario de Valencia
Hospital Universitario La Fe
Information provided by (Responsible Party):
M. Antonia Pérez-Marín, University of Valencia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Allergic Rhinitis Allergic Asthma Asthma Short Stature Food Allergy Atopic Dermatitis Rhinoconjunctivitis Cystic Fibrosis Primary Ciliary Dyskinesia Pulmonary Disease Other: Ten Vida (10Vida) Not Applicable

Detailed Description:

Adolescence is a period characterized by a multitude of changes at the biopsychosocial level, all of which also implies many challenges. If the diagnosis or the presence of a chronic disease or condition (CD) is added, the adjustment of the adolescent to this period become even more difficult.

The World Health Organization (WHO) (2017) defines chronic diseases (CD) as "long-lasting and usually slow-progressing diseases". Among the main child-juvenile CDs are the allergic, the endocrine; in particular, Diabetes Mellitus Type 1 (DM1) and Short stature (SS), and respiratory, such as bronchial asthma (BA).

Chronic pediatric disease is a medical condition that affects both the patient and the family caregiver. Chronic disease is characterized by unforeseeable changes in the course of the disease, a reduction in physical capacity, changes in appearance, a prolonged dependence on medical specialists, continuous treatments and the need for assistance.

The presence of CD in adolescence is a risk factor for developing a psychological disorder. The most common psychopathology in childhood-juvenile CD is emotional, particularly anxiety symptoms, followed by depression symptoms, being possible the development of an anxiety disorder or of a major depression.

When someone is diagnosed with a chronic disease, the family as a whole is affected by the stressors associated with the disease and the side effects of treatment, being inevitable the alteration of the whole family system, especially in cases where the patient is a infant or adolescent. In addition, it is necessary to underline that studies indicate that most of the care of adolescent patients generally is undertaken by one specific member of the family, usually called the main caregiver. The stress due to the care tasks has been associated with anxiety and depression symptoms, often causing emotional disturbances in the caregivers, associating the above with greater emotional symptomatology in adolescents and worse control of their disease.

That's why more studies like the one proposed are needed to study more deeply the protective factors of psychological and physical health during the course of chronic disease at this stage of life, both in the adolescent patients as well as in their family.

The main aim of this research is to study the psychosocial factors, adjustment to the disease and improvement of psychological well-being in the adolescent population with chronic disease. In order to do this, the investigators are going to analyse the main characteristics (psychological, family related and adjustment to disease) in the adolescent population with endocrinological problems (short stature and diabetes mellitus type 1), respiratory (asthma) and allergenic problems. These characteristics will also be analysed in the family of the adolescent patients. The personal adaptation profiles and families features that favor the psychological and physical health in these patients and their family caregivers will be also identified. In addition, the investigators also propose as an aim the development and implementation of an assessment and intervention program (in a pilot sample) that provides socio-emotional education in adolescent patients with chronic disease and their family caregivers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : February 4, 2023


Arm Intervention/treatment
No Intervention: Control Group
Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental: Experimental Group
Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group). Thus, diagnostic measures will be obtained in all of them in an initial evaluation (T1), and after 6 months of this evaluation the treatment program will be started. In the first contact session at 6 months after T1 all subjects (patients and relatives) will be re-evaluated (T2) and after this the treatment program will be started (within an estimated time of 15 days maximum from this second pre-treatment evaluation, the estimated duration of treatment being 5 months). After the completion of the patient and family treatment sessions, a new diagnostic test pass will be performed (T3) (within an estimated maximum period of 15 days from the completion of treatment) in order to evaluate the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 6 months.
Other: Ten Vida (10Vida)
10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.




Primary Outcome Measures :
  1. Change Emotional Distress in caregivers (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.


  2. Change Emotional Distress in patients (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.


  3. Change Caregiver burden (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.



Secondary Outcome Measures :
  1. Change Resilience in caregivers (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.


  2. Change Self-esteem in patients (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up of 10 items, the range of scores being from 10 to 40. Higher scores indicated better self-esteem.

    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.


  3. Change of Emotional competence (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    Emotional Skills and Competence Questionnaire: with the aim of evaluating emotional competence. There are 3 dimensions: emotional expression, labeling and emotional regulation, each of the scales varies from 1 to 6 ( as it is calculated through the average), higher scores indicate better skills in emotional intelligence.

    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.


  4. Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.


  5. Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post [ Time Frame: Baseline up to 12 months ]

    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.


  6. Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.


  7. Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    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.


  8. Change of Perceived level of disease threat (Baseline-Pre-Post) [ Time Frame: Baseline up to 12 months ]

    Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive and emotional representations of their disease. The range of scores of this scale is from 0-10. The higher the total score, the greater the perception of the disease as a threat.

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476433


Contacts
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Contact: Marián Pérez-Marín, PhD 0034 9639 ext 83392 marian.perez@uv.es
Contact: Inmaculada Montoya-Castilla, PhD 0034 9639 ext 83433 inmaculada.montoya@uv.es

Locations
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Spain
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Marián Pérez-Marín, PhD    0034 9639 ext 83392    marian.perez@uv.es   
Sponsors and Collaborators
University of Valencia
Hospital General Universitario de Valencia
Hospital Clínico Universitario de Valencia
Hospital Universitario La Fe
Investigators
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Principal Investigator: Marián Pérez-Marín, PhD University of Valencia
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Responsible Party: M. Antonia Pérez-Marín, Associate Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT04476433    
Other Study ID Numbers: FACTORADAPT
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M. Antonia Pérez-Marín, University of Valencia:
Caregivers
Adolescent
Anxiety
Depression
Quality of life
Intervention Study
Additional relevant MeSH terms:
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Asthma
Cystic Fibrosis
Ciliary Motility Disorders
Dyskinesias
Dermatitis
Food Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Skin Diseases
Otorhinolaryngologic Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities