- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02056431
Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. Several prescription medications are available for the treatment of DPN symptoms, but none work perfectly and all have side effects that may be difficult for some patients.
When patients report their symptoms and side effects to their doctor, they provide the doctor with important information to help them make adjustments to treatment that will help with symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors may encourage patients to make these changes on their own at home based on their experience with therapy. However, patients may have a long time between visits to their doctor and may have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit.
This clinical trial explores the possibility of computerized telephone calls to patients (Interactive Voice Response, IVR, technology) to gather information about treatment experiences that can then be reported to the doctor or used to guide patients to make changes in how they take the medication. It addresses the following question: Can routinely asking patients about their experiences with medications and using that information to encourage clinically appropriate titration improve patient quality of life?
The investigators hypothesize that systematic collection and feedback of information about DPN treatment preferences and experience from newly treated patients to their primary care physician will facilitate treatment changes that improve patient outcomes
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Among newly-treated Diabetic Peripheral Neuropathy (DPN) patients, the investigators will compare the systematic collection and feedback of information about patients' treatment experiences on changes in quality of life (intervention group) to newly treated DPN patients in usual care who will receive generic educational messages by phone but no active data collection and feedback (comparator group). The investigators have chosen usual care as the control to evaluate the potential for the intervention to enhance current practice.
Aim 1: Refine and pilot test instruments for collecting the patient-reported data most important for guiding changes in treatment.
Aim 2: Implement a seven-month cluster randomized trial to improve quality of life among patients newly treated for DPN symptoms by collecting data on patient treatment experiences and facilitating evidence-based patient and provider-initiated treatment titration.
Aim 3: Examine patient and physician initiated treatment changes as secondary outcomes in order to inform the development of this type of rapid feedback process for guiding decision making about initial treatment selection among patients with DPN.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
California
-
Oakland, California, Yhdysvallat, 94612
- Division of Research Kaiser Permanente
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- All patients newly prescribed medication to treat diabetic peripheral neuropathy symptoms.
Exclusion Criteria:
- Patients with any evidence of use of diabetic peripheral neuropathy study medications.
- Patients with evidence of gestational diabetes (ICD-9: 648.8) due to variation in treatment and monitoring for women who are pregnant.
- Patients who simultaneously received a new diagnosis for depression or seizure conditions
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: IVR Intervention Group
Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
|
Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
|
|
Ei väliintuloa: IVR Control Group
Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Patient Quality of Life at Baseline and 8 Months
Aikaikkuna: Baseline and 8 months
|
The primary outcome measure is change in quality of life from baseline at eight months following study entry.
We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures.
The range for EQ-5D is 0-1, with "0" being the worst and "1" being the best.
|
Baseline and 8 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants With Minimally Effective Dose in 12 Months
Aikaikkuna: 12 months
|
Count of patients who ever received a minimally effective dose of the medications they started on during the 12 months following treatment start (measured post only).
|
12 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Alyce S. Adams, PhD, Kaiser Permanente
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Adams AS, Bayliss EA, Schmittdiel JA, Altschuler A, Dyer W, Neugebauer R, Jaffe M, Young JD, Kim E, Grant RW; Diabetes Telephone Study Team. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment. Clin Trials. 2016 Jun;13(3):286-93. doi: 10.1177/1740774516631530. Epub 2016 Mar 31.
- Adams AS, Schmittdiel JA, Altschuler A, Bayliss EA, Neugebauer R, Ma L, Dyer W, Clark J, Cook B, Willyoung D, Jaffe M, Young JD, Kim E, Boggs JM, Prosser LA, Wittenberg E, Callaghan B, Shainline M, Hippler RM, Grant RW. Automated symptom and treatment side effect monitoring for improved quality of life among adults with diabetic peripheral neuropathy in primary care: a pragmatic, cluster, randomized, controlled trial. Diabet Med. 2019 Jan;36(1):52-61. doi: 10.1111/dme.13840. Epub 2018 Nov 7.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CE-1304-7250
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .