Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
1. juni 2017 opdateret af: Deborah Ellis, Ph.D., Wayne State University
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
The purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior.
The intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of Motivational Interviewing.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The study includes a development phase (Phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2: pilot randomized clinical trial (RCT)] using a sample of 90 African American youth transitioning to independent diabetes care and their parents.
In this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3).
In phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability.
In phase 2 ( RCT), families will complete three intervention plus data collection visits and one additional data collection only visit.
Research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
145
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år til 13 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- African American race/ethnicity
- Age: 10 years 0 months - 12 years, 11 months
- Type 1 diabetes mellitus
- Diagnosed at least 6 months
- Patient of Children's Hospital of Michigan Diabetes Clinics
- English fluency, both verbal and written
Exclusion Criteria:
- Psychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. Youth with current suicidal intent are not enrolled until psychiatrically stable.
- Medical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. Other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Active Caregiver and Active Child
Parent & Child Computer-Delivered Motivational Intervention will be delivered to participants.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered behavior change counseling intervention for children with diabetes to improve completion of daily diabetes care.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding diabetes care.
|
|
Eksperimentel: Active Caregiver and Child Education
Parent Computer-Delivered Motivational Intervention will be delivered to the parents only.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered informational session about diabetes related topics for their child with diabetes.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding monitoring diabetes care.
|
|
Aktiv komparator: Education Caregiver/Education Child
Participants will receive computer-delivered information.
A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
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Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diabetes Management Scale
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
|
Each of 3 intervention session, 3-4 month apart
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Regulation Questionnaire
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
Parental motivation to monitor the youth is measured by the Treatment Self-Regulation Questionnaire (TSRQ; Ryan & Connell (1989).
The TSRQ evaluates why people engage in a health-relevant behavior and assesses the degree to which one's motivation for a particular behavior or set of behaviors is relatively autonomous or self-determined as compared to derived from external pressures or constraints.
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Each of 3 intervention session, 3-4 month apart
|
|
Readiness Ruler
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
Parent motivation to monitor the youth is also measured by the Readiness Ruler (Stott, Rollnick, & Pill, 1995).
Since readiness to change behaviors is behavior specific, the items will be tailored to assess the behaviors most critical to parental monitoring of diabetes management.
The response format is a visual analog scale (VAS) 10 mm in length.
Written cues anchor the ends and middle of the scale.
Respondents mark their "readiness" on the scale and the position on the line is measured in millimeters.
|
Each of 3 intervention session, 3-4 month apart
|
|
HbA1C Blood Test
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
Metabolic control will be measured via hemoglobin A1c (HbA1c).
HbA1c is an indirect and retrospective measure of average blood glucose levels over the previous two to three month period.
|
Each of 3 intervention session, 3-4 month apart
|
|
Parental Monitoring of Diabetes Care
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
The Parental Monitoring of Diabetes Care scale (PMDC) is an 18 item, investigator-developed questionnaire that measures the frequency of parental monitoring and direct supervision of diabetes care tasks such as insulin administration, blood glucose testing, and dietary management.
|
Each of 3 intervention session, 3-4 month apart
|
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Twenty-four Hour Recall Interview
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
The Twenty-four Hour Recall Interview, developed by Johnson and colleagues (Freund, Johnson, Silverstein et al., 1991), has been used extensively in pediatric diabetes research for the assessment of illness management.
|
Each of 3 intervention session, 3-4 month apart
|
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Blood Glucose Testing Frequency
Tidsramme: Each of 3 intervention session, 3-4 month apart
|
Objective data on mean daily frequency of blood glucose testing during the 14-day period prior to data collection will be obtained directly from blood glucose meters.
|
Each of 3 intervention session, 3-4 month apart
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Deborah A Ellis, Ph.D., Wayne State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2011
Primær færdiggørelse (Faktiske)
3. marts 2014
Studieafslutning (Faktiske)
9. september 2014
Datoer for studieregistrering
Først indsendt
18. januar 2012
Først indsendt, der opfyldte QC-kriterier
23. januar 2012
Først opslået (Skøn)
24. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3M's Diabetes Study
- R21DK089238 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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