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Improving Medication Adherence in the Alabama Black Belt

6 oktober 2020 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

473

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35210
        • Univeristy of Alabama at Birmingham

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

19 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Self Reported Medication Adherence
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 6 months
Finger stick, spectrophotometer to measure cholesterol level.
Baseline, 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
6 months
Number of Hospital Stays at 6 Months
Tidsram: 6 months
6 months
Number of Emergency Visits at 6 Months
Tidsram: 6 months
6 months
Change in Diabetes Medication Counts
Tidsram: Baseline, 6 months
Change in number of diabetes medications.
Baseline, 6 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2016

Primärt slutförande (Faktisk)

31 januari 2019

Avslutad studie (Faktisk)

31 januari 2019

Studieregistreringsdatum

Först inskickad

14 oktober 2014

Först inskickad som uppfyllde QC-kriterierna

22 oktober 2014

Första postat (Uppskatta)

24 oktober 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 oktober 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • PCORI-R-AD-1306-03565

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Data will stay at UAB

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