- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07794384
Effects of a Researcher-Designed Diabetes Self-Management App on Self-Management Obstacles, Self-Efficacy, and Physiological Indicators in Type 2 Diabetes (Application)
28. august 2026 oppdatert av: SZU-YI WANG, Fu Jen Catholic University Hospital
Construction and Evaluation of a Self-management APP for Effectiveness in Self-Management, Self-Efficacy, and Metabolic Indicators of Patients With Type 2 Diabetes.
This study aims to evaluate the effectiveness of a self-developed diabetes self-management mobile application on disease self-management outcomes among individuals with type 2 diabetes.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Diagnosed with type 2 diabetes for more than 6 months and Hemoglobin A1c (HbA1c) > 7.5%.
- Having diabetes self-management obstacles.
- Aged 18 years or older.
- Conscious and able to communicate.
- Having a smartphone with internet access.
- Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
- Gestational diabetes mellitus.
- Currently taking steroid medications.
- Having a severe infection requiring hospitalization within the past 6 months.
- Unable to perform self-care independently.
- Having participated in or currently participating in an educational program of a similar nature.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Basic self-management mobile application use.
Participants in the control group will receive routine diabetes care and use the basic functions of the diabetes self-management mobile application.
The basic app functions include self-recording of blood glucose, medication, diet, physical activity, and related health information.
Participants in this group will not receive additional video-based health education or multidisciplinary team care through the application.
|
|
|
Eksperimentell: Enhanced diabetes self-management mobile application use.
Participants in the intervention group will receive routine diabetes care and access to an enhanced diabetes self-management mobile application, which includes basic self-management recording functions, video-based health education, and multidisciplinary team care to support diabetes self-management.
|
Participants in the intervention group will receive routine diabetes care and use the enhanced diabetes self-management mobile application.
In addition to the basic self-management recording functions, the intervention group will receive video-based health education and multidisciplinary team care through the application.
The multidisciplinary team may include healthcare professionals such as physicians, nurses, dietitians, and pharmacists, who provide diabetes-related guidance to support daily self-management, self-efficacy, and metabolic control.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diabetes management self-efficacy
Tidsramme: Baseline, 3 months, and 6 months.
|
|
Baseline, 3 months, and 6 months.
|
|
Diabetes self-management obstacles
Tidsramme: Baseline, 3 months, and 6 months.
|
Diabetes self-management obstacles will be measured using the Chinese Version of the Diabetes Obstacles Questionnaire-Short Form (CDOQ-S).
Each item is rated on a 5-point Likert scale, ranging from 1 to 5. The items are negatively scored, and higher scores indicate greater obstacles in diabetes self-management.
|
Baseline, 3 months, and 6 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c
Tidsramme: Baseline, 3 months, and 6 months
|
Glycated hemoglobin (HbA1c) will be measured using laboratory blood tests and reported as a percentage (%)
|
Baseline, 3 months, and 6 months
|
|
Fasting plasma glucose
Tidsramme: Baseline, 3months, and 6months
|
Fasting plasma glucose will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
|
Baseline, 3months, and 6months
|
|
Triglycerides
Tidsramme: Baseline, 3months, and 6 months
|
Serum triglyceride levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
|
Baseline, 3months, and 6 months
|
|
Total cholesterol
Tidsramme: Baseline, 3 months, and 6 months.
|
Serum total cholesterol levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
|
Baseline, 3 months, and 6 months.
|
|
LDL
Tidsramme: Baseline, 3 months, and 6 months.
|
Serum low-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
|
Baseline, 3 months, and 6 months.
|
|
HDL
Tidsramme: Baseline, 3 months, and 6 months.
|
Serum high-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
|
Baseline, 3 months, and 6 months.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
31. juli 2028
Studiet fullført (Antatt)
31. juli 2028
Datoer for studieregistrering
Først innsendt
24. august 2026
Først innsendt som oppfylte QC-kriteriene
28. august 2026
Først lagt ut (Faktiske)
31. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FJUH114464
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