Type 1 DiabetesFACTORADAPTNCT04476433
Intervention in Chronic Pediatric Patients and Their Families.
A study testing Ten Vida (10Vida) in people with Type 1 Diabetes and Allergic Rhinitis, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Allergic Rhinitis, Allergic Asthma
- What is being tested?
- Ten Vida (10Vida)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis at least 6 months.
- To have signed the informed consent.
Who cannot join
- No previous psychological diagnosis.
- Attention Deficit Hyperactivity Disorder(ADHD), epilepsy or brain tumor
- Infant cerebral palsy
- Not understanding the Spanish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Allergic Rhinitis, Allergic Asthma, Asthma, Short Stature, Food Allergy
- Being tested
- Ten Vida (10Vida)
- Keywords
- Caregivers, Adolescent, Anxiety, Depression, Quality of life, Intervention Study
- Medical subject headings
- Diabetes Mellitus, Type 1, Rhinitis, Allergic, Asthma, Dwarfism, Food Hypersensitivity, Dermatitis, Atopic, Cystic Fibrosis, Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ten Vida (10Vida)Other
10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group). |
| Experimental Group | Experimental | 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. Receives: Other: Ten Vida (10Vida) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
Change Emotional competences in patients (Baseline-Pre-post)
Emotional Skills and Competence Questionnaire (ESCQ-21): this is a self-report measure developed by Takšić 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)
Measured: Baseline up to 12 months
Change Self-esteem in patients (Baseline-Pre-Post)
Rosenberg Self-Esteem Questionnaire. It assesses the level of self-esteem. It is made up
Measured: Baseline up to 12 months
Change of Perceived level of disease threat (Baseline-Pre-Post)
Brief Disease Perception Questionnaire (B-IPQ): This is a measure of patients' cognitive
Measured: Baseline up to 12 months
Secondary outcomes (8)
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.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start4 Feb 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario de Valencia, Hospital Clínico Universitario de Valencia, Hospital Universitario La Fe
- Responsible party
- Principal investigator, M. Antonia Pérez-Marín, University of Valencia
- Investigators
- Marián Pérez-Marín, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476433
- Sponsor's protocol ID
- FACTORADAPT
- Acronym
- FACTORADAPT
- Status last verified
- Mar 2024
- First submitted
- 3 Jul 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Program in Chronic Pediatric Patients With Different Pathologies and in Their Families.
- ClinicalTrials.gov ID
- NCT04476433
- Acronym / sponsor ID
- FACTORADAPT / FACTORADAPT
- Conditions
- Type 1 Diabetes, Allergic Rhinitis, Allergic Asthma, Asthma, Short Stature, Food Allergy
- Keywords
- Caregivers, Adolescent, Anxiety, Depression, Quality of life, Intervention Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital General Universitario de Valencia, Hospital Clínico Universitario de Valencia, Hospital Universitario La Fe
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients and caregivers who receive the treatment program, will previously constitute their own control group (waiting list control group). |
| Experimental Group | Experimental | Other: Ten Vida (10Vida)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. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis at least 6 months.
- To have signed the informed consent.
Key exclusion criteria (4 listed)
- No previous psychological diagnosis.
- Attention Deficit Hyperactivity Disorder(ADHD), epilepsy or brain tumor
- Infant cerebral palsy
- Not understanding the Spanish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ten Vida (10Vida)10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families. | Other | Experimental Group |
Primary outcome
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.
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.
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.
Change Emotional competences in patients (Baseline-Pre-post)
Time frame: Baseline up to 12 months
Emotional Skills and Competence Questionnaire (ESCQ-21): this is a self-report measure developed by Takšić 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)
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
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
8 secondary outcomes
Change Resilience in caregivers (Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Change of Adaptation to chronic disease (DM1) (Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Change of Adaptation to chronic disease (Respiratory chronic diseases) (Baseline-Pre-Post
Time frame: Baseline up to 12 months
Change of Adaptation to chronic disease (Rhinoconjunctivitis) (Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Change of Adaptation to chronic disease (Food Allergy)(Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Change in family functioning in caregivers (Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Change in parental styles in patients (Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Change Psychological well-being (Baseline-Pre-Post)
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marián Pérez-Marín, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ten Vida (10Vida) in people with Type 1 Diabetes and Allergic Rhinitis, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Emotional Distress in caregivers (Baseline-Pre-Post) (time frame: Baseline up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.