Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Insulin Start Therapy Application With Resources and Training (I-START)

7. července 2022 aktualizováno: Linda Siminerio, University of Pittsburgh

Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy

The purpose of the I-START study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (T2DM) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Despite advances in technology and delivery systems, patients with T2DM continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons. Introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints. Teaching people to administer an insulin injection requires time and ongoing support. Therefore, this study aims to evaluate an educational phone application designed to support patients with T2DM by reinforcing skills and self-management behaviors needed for insulin administration. Patients with T2DM who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.

Typ studie

Intervenční

Zápis (Aktuální)

41

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 18 years of age
  • Able to read and follow study instructions in English (translations will not be provided)
  • T2DM requiring the use of prandial and/or long-acting insulin
  • Ability to self-administer insulin therapy
  • Willing to download the study app on their smartphone
  • Able and willing to provide a signed consent
  • Able and willing to follow all study procedures

Exclusion Criteria:

  • Pregnant (self-reported)
  • Participants from the same household participating concurrently
  • Use of a smartphone with iOS version 10.0 or lower
  • Use of a smartphone with Android OS 5.0 "Lollipop" or lower
  • Currently using a continuous subcutaneous insulin infusion device
  • Participants with major depression
  • Currently or planning to participate in a similar study that would affect the results of this study
  • Currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug
  • Continued hospitalization or transfer to an assisted living facility
  • Any condition the PI or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention
Participants assigned to the intervention group will receive insulin administration education according to standard procedures plus have access to the I-START app. Over the course of the study period, participants will be able to use I-START as much or as little as they prefer.
Behaviorální: I-START
Designed as a supplementary educational tool for patients on insulin therapy, I-START includes an injection plan to reinforce the knowledge and behaviors that users have been taught by their health care provider. This is done through eight modules created for the benefit of new and experienced insulin users, and those using pens or vial/syringes. The modules address a variety of topics pertinent to insulin therapy, including overcoming psychosocial barriers, injection techniques and best practices, managing hypo- and hyperglycemic events, monitoring blood glucose and troubleshooting and problem solving. At the end of each module, users can self-evaluate their confidence in mastering the information presented. This gives them the ability to move forward into the next module, repeat material already presented and/or save features of the modules that they would like to revisit at another time.
Behaviorální: Standard Insulin Administration Education
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
Aktivní komparátor: Usual Care
Participants in the usual care group will receive insulin administration education according to standard procedures. They will not have access to the I-START app.
Behaviorální: Standard Insulin Administration Education
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in psychological insulin resistance at 2 weeks
Časové okno: 2 weeks
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
2 weeks
Change from baseline in psychological insulin resistance at 3 months
Časové okno: 3 months
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
3 months
Change from baseline in psychological insulin resistance at 6 months
Časové okno: 6 months
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in glycemic control at 3 months
Časové okno: 3 months
Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control. HbA1c will serve as the clinical study outcome and measure of glycemic control. HbA1c values will be obtained from the electronic medical record (EMR) system.
3 months
Change from baseline in glycemic control at 6 months
Časové okno: 6 months
Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control. HbA1c will serve as the clinical study outcome and measure of glycemic control. HbA1c values will be obtained from the electronic medical record (EMR) system.
6 months
Change from baseline in medication adherence at 3 months
Časové okno: 3 months
Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). The scales includes 8 items. Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
3 months
Change from baseline in medication adherence at 6 months
Časové okno: 6 months
Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
6 months
Change from baseline in diabetes empowerment at 3 months
Časové okno: 3 months
Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.
3 months
Change from baseline in diabetes empowerment at 6 months
Časové okno: 6 months
Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.
6 months
Change from baseline in diabetes distress at 3 months
Časové okno: 3 months
Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
3 months
Change from baseline in diabetes distress at 6 months
Časové okno: 6 months
Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
6 months
Patient Satisfaction
Časové okno: 6 months
Patient satisfaction will be assessed using the validated Diabetes Medication System Rating Questionnaire-Short Form (DMSRQ-SF) (Peyrot et al, 2014). Items are scored 0 to 100; higher scores equal greater levels of item/construct being measured.
6 months
Provider Satisfaction
Časové okno: 6 months
Clinician experiences and perspectives on satisfaction of the app will be assessed through a study specific satisfaction survey
6 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient Usability
Časové okno: 6 months
Patient usability will be tracked through the app's data analytics software platform. Study staff will pull data from the data analytics software platform.
6 months
Provider usability
Časové okno: 6 months
Clinician experiences and perspectives on the usability of the Briight app will be assessed a study specific usability survey.
6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Pittsburgh

Vyšetřovatelé

  • Vrchní vyšetřovatel: Linda Siminerio, RN, PhD, CDE, PROFESSOR

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. listopadu 2019

Primární dokončení (Aktuální)

25. května 2022

Dokončení studie (Aktuální)

25. května 2022

Termíny zápisu do studia

První předloženo

21. června 2019

První předloženo, které splnilo kritéria kontroly kvality

25. června 2019

První zveřejněno (Aktuální)

26. června 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. července 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2022

Naposledy ověřeno

1. července 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STUDY19040017

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified data set used for final analysis will be made available to other researchers who have obtained appropriate regulatory approval

Časový rámec sdílení IPD

Data Set - After publication. ICF - After completing data collection.

Kritéria přístupu pro sdílení IPD

Data set - other researchers will have to request access. ICF will be added to clinicaltrials.gov protocol

Typ podpůrných informací pro sdílení IPD

  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Diabetes mellitus, typ 2

Klinické studie na I-START

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Turkmenistan

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit