- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 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.
|
|
|
Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diabetes management self-efficacy
Tidsramme: Baseline, 3 months, and 6 months.
|
|
Baseline, 3 months, and 6 months.
|
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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 |
Foranstaltningsbeskrivelse |
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.
|
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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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. juli 2028
Studieafslutning (Anslået)
31. juli 2028
Datoer for studieregistrering
Først indsendt
24. august 2026
Først indsendt, der opfyldte QC-kriterier
28. august 2026
Først opslået (Faktiske)
31. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FJUH114464
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