- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02746627
Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D
Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes
Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.
Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosed with type 1 diabetes for at least 6 months
- HbA1c between 8-12%
- Speak and read English
- Caregiver living with child
Exclusion Criteria:
- Other uncontrolled health conditions
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Education
Participants receive educational materials in the mail every 2 weeks for 8 weeks.
|
Educational materials on diabetes management
|
|
Sperimentale: Positive Affect - Text
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS.
Participants also receive educational materials in the mail every 2 weeks for 8 weeks.
|
Educational materials on diabetes management
Positive psychology intervention to improve motivation for diabetes management.
|
|
Sperimentale: Positive Affect - Phone
Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone.
Participants receive small gifts in the mail every 2 weeks for 8 weeks.
educational materials in the mail every 2 weeks for 8 weeks.
|
Educational materials on diabetes management
Positive psychology intervention to improve motivation for diabetes management.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Glycemic Control (HbA1c)
Lasso di tempo: 6 months
|
HbA1c measured as part of diabetes clinic visit.
The target for children and adolescents is <7.5%.
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Frequency of Blood Glucose Monitoring
Lasso di tempo: 6 months
|
Glucometer download to determine blood glucose checks per day.
|
6 months
|
|
Diabetes-Related Quality of Life
Lasso di tempo: 6 months
|
The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life.
Scaled scores range from 0-100, with higher scores indicating better quality of life.
|
6 months
|
|
Family Conflict
Lasso di tempo: 6 months
|
Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks.
Scores range from 19-57, and higher scores indicate greater conflict.
|
6 months
|
|
Positive Affect
Lasso di tempo: 6 months
|
Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C).
The positive affect scale consists of 15 items.
Scores range from 15-75, and higher scores indicate higher levels of positive affect.
|
6 months
|
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Coping
Lasso di tempo: 6 months
|
Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress.
Scores range from 57-228, and higher scores indicate more responses to stress.
|
6 months
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 131384
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .