- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02274844
Improving Medication Adherence in the Alabama Black Belt
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal.
Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are:
Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing.
Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes).
This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35210
- Univeristy of Alabama at Birmingham
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- adults
- type 2 diabetes
- taking medications for diabetes
- medication non adherent
Exclusion Criteria:
- nursing home residence
- plans to move away in the next year
- advanced illnesses such as hemodialysis, cancer or dementia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Peer Coaching
The intervention participants will receive the Living Well with Diabetes Program.
The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
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The intervention participants will receive the Living Well with Diabetes Program.
The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
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Aucune intervention: Usual Care
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care.
There will be no peer storytelling on these DVDs.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Self Reported Medication Adherence
Délai: Baseline, 6 months
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Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
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Baseline, 6 months
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Change in Percentage of HbA1c
Délai: Baseline, 6 months
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Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
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Baseline, 6 months
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Change in Blood Pressure
Délai: Baseline, 6 months
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2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
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Baseline, 6 months
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Change in Low-Density Lipoprotein (LDL) Cholesterol
Délai: Baseline, 6 months
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Finger stick, spectrophotometer to measure cholesterol level.
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Baseline, 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Délai: Baseline, 6 months
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Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
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Baseline, 6 months
|
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Change in Quality of Life as Assessed With the Short Form-12- Physical Component
Délai: Baseline, 6 months
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Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
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Baseline, 6 months
|
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Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
Délai: Baseline, 6 months
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Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
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Baseline, 6 months
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Change in Diabetes-Specific Quality of Life
Délai: Baseline, 6 months
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Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress.
Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem).
A score of 3 or greater = moderate distress.
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Baseline, 6 months
|
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Number of Physician Office Visits 6 Months
Délai: 6 months
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6 months
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Number of Hospital Stays at 6 Months
Délai: 6 months
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6 months
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Number of Emergency Visits at 6 Months
Délai: 6 months
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6 months
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Change in Diabetes Medication Counts
Délai: Baseline, 6 months
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Change in number of diabetes medications.
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Baseline, 6 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Délai: Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Délai: Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Délai: Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Délai: Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Monika M Safford, MD, Weill Medical College of Cornell University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PCORI-R-AD-1306-03565
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .