- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02197611
Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. (ADHAESIONE)
Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. The Haemo-Adhaesione Questionnaire
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
- Descriptive study for the construction of a multidimensional scale of adherence to treatment in adult patients with hemophilia.
- Validation of a scale specific measure for patients with hemophilia that includes 5 dimensions that may affect adherence to treatment: a) the doctor-patient, b) regarding knowledge of the disease, c) the previous hemorrhages, d) knowledge future sequels, e) difficulties with treatment.
- Statistical and psychometric analysis of the adherence questionnaire for adult patients with hemophilia.
- Description of the theoretical framework that justifies the completion of the questionnaire, and the choice of the dimensions and items that make up the measurement scale.
- The questionnaire obtained in this project will identify the actual degree of patient adherence to multidisciplinary treatment, taking as gold standard, compliance with pharmacological treatment (the difference between the treatment prescribed and consumed).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: RUBÉN CUESTA-BARRIUSO, PhD
- Telefonnummer: 968278806
- E-post: ruben.cuestab@gmail.com
Studera Kontakt Backup
- Namn: Ana Torres-Ortuño, PhD
- Telefonnummer: 868887170
- E-post: atorres.ortuno@gmail.com
Studieorter
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Murcia, Spanien, 30100
- Rekrytering
- Universidad de Murcia
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Kontakt:
- RUBÉN CUESTA-BARRIUSO, PhD
- Telefonnummer: 968278806
- E-post: ruben.cuestab@gmail.com
-
Kontakt:
- Ana Torres-Ortuño, PhD
- Telefonnummer: 868887170
- E-post: atorres.ortuno@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients diagnosed with hemophilia A or B.
- Patients over 18 years of age.
Exclusion Criteria:
- Patients with neurological or cognitive impairments that hinder oral and written comprehension.
- Patients who have not signed the informed consent document
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Validation group
Group of patients who we will consult the characteristics of the scale designed and will be made the statistical calculations of validity, reliability and reproducibility
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Phase substantive for the creation of a scale
Tidsram: Screening visit
|
The theoretical framework and objectives for the creation of the scale is created. The questionnaire was developed teóricasdel dimensions and items of each dimension are identified. In this testing phase, the pilot is 5 Hematologists physicians experienced in hemophilia (no contact between them) and a sample of the target population (± 12 patients with hemophilia). The structure of this phase include:
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Screening visit
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Structural phase for the creation of a scale
Tidsram: Screening visit
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This phase is carried out the questionnaire to a pilot sample (± 50 patients with hemophilia) and the choice of format is made. Similarly, an analysis of differential functioning or bias of the items is performed. The structure of this phase include:
|
Screening visit
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Empirical phase for the creation of a scale
Tidsram: Screening visit
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This phase is carried out applying the scale to a general sample (patient 100-150). After the statistical and convergence and discriminant analysis (other scales) and the study of responsibility (with drug consumption data) will be made. The structure of this phase include:
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Screening visit
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Haemo Adhaesione
- Haemo-Adhaesione (Annan identifierare: UMurcia)
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