- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03544645
Are Audiovisual Materials Superior to Printed Materials in Improving Awareness Among Type 2 Diabetic Patients? (SA)
Are Audiovisual Educational Materials Superior to Printed Educational Materials in Improving Insulin Awareness Among Saudi Type 2 Diabetic Patients in Primary Care Setting?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Introduction This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.
Methodology It's a randomized controlled trial. Validated questionnaire (ITAS) was used to evaluate the psychological insulin barriers, video and Brochures were devolved as educational materials contain same contents and validated. Study conducted in King Abdulaziz city housing with total sample size of 126. They were divided into intervention group (video group) and controlled group (Brochure group). Both group filled the same questionnaire before the intervention. And then immediately after the intervention. Six weeks later, both groups filled the same questionnaire to measure the long-term effects.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Riyadh, Saudi Arabien, 14611
- King Saud Bin Abdulaziz University for Health Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type 2 diabetic patients
- Age group from 30 to 70 years
- A1c = 8 mg/dL or above
- Both genders
Exclusion Criteria:
- Pregnant women
- Blindness or profound vision loss
- Severe mental problems e.g. Psychosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: control group
This group received a printed material "brochure" as an educational material
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an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.
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Eksperimentel: intervention group
This group received an audiovisual material "video" as an educational material
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an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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compare the impact of audiovisual educational materials verses printed educational materials
Tidsramme: 6 weeks
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compare intervention versus control on type 2 diabetic patients' knowledge, attitude and practice towards insulin therapy by assessing the patients before, directly after and 6 weeks after the intervention using a validated questionnaire (ITAS) to evaluate the psychological insulin barriers, both intervention and control were devolved as educational materials contain same contents and validated
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6 weeks
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KingAbdullahIMRC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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