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Improving Medication Adherence in the Alabama Black Belt

6 octobre 2020 mis à jour par: Weill Medical College of Cornell University
Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. 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.

Aperçu de l'étude

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

Interventionnel

Inscription (Réel)

473

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Alabama
      • Birmingham, Alabama, États-Unis, 35210
        • Univeristy of Alabama at Birmingham

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

19 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
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.
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
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Self Reported Medication Adherence
Délai: Baseline, 6 months
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Baseline, 6 months
Change in Percentage of HbA1c
Délai: Baseline, 6 months
Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
Baseline, 6 months
Change in Blood Pressure
Délai: Baseline, 6 months
2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
Baseline, 6 months
Change in Low-Density Lipoprotein (LDL) Cholesterol
Délai: Baseline, 6 months
Finger stick, spectrophotometer to measure cholesterol level.
Baseline, 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Délai: Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Baseline, 6 months
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
Délai: Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Baseline, 6 months
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
Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
Baseline, 6 months
Change in Diabetes-Specific Quality of Life
Délai: Baseline, 6 months
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.
Baseline, 6 months
Number of Physician Office Visits 6 Months
Délai: 6 months
6 months
Number of Hospital Stays at 6 Months
Délai: 6 months
6 months
Number of Emergency Visits at 6 Months
Délai: 6 months
6 months
Change in Diabetes Medication Counts
Délai: Baseline, 6 months
Change in number of diabetes medications.
Baseline, 6 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Délai: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
Délai: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
Délai: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
Délai: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Monika M Safford, MD, Weill Medical College of Cornell University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2016

Achèvement primaire (Réel)

31 janvier 2019

Achèvement de l'étude (Réel)

31 janvier 2019

Dates d'inscription aux études

Première soumission

14 octobre 2014

Première soumission répondant aux critères de contrôle qualité

22 octobre 2014

Première publication (Estimation)

24 octobre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 octobre 2020

Dernière vérification

1 octobre 2020

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)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Data will stay at UAB

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 .

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