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

7 juli 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

41

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • University of Pittsburgh Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in psychological insulin resistance at 2 weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in glycemic control at 3 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months
Clinician experiences and perspectives on satisfaction of the app will be assessed through a study specific satisfaction survey
6 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Usability
Tijdsspanne: 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
Tijdsspanne: 6 months
Clinician experiences and perspectives on the usability of the Briight app will be assessed a study specific usability survey.
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pittsburgh

Onderzoekers

  • Hoofdonderzoeker: Linda Siminerio, RN, PhD, CDE, Professor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 november 2019

Primaire voltooiing (Werkelijk)

25 mei 2022

Studie voltooiing (Werkelijk)

25 mei 2022

Studieregistratiedata

Eerst ingediend

21 juni 2019

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2019

Eerst geplaatst (Werkelijk)

26 juni 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juli 2022

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2022

Laatst geverifieerd

1 juli 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY19040017

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus, type 2

Klinische onderzoeken op I-START

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