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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

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.
  1. The Chinese version of the Diabetes Management Self-Efficacy Scale(C-DMSES) includes 20 items across four subscales:

    1. Nutrition: 9 items
    2. Physical activity and weight control: 4 items
    3. Medication treatment: 3 items
    4. Blood glucose and foot care: 4 items
  2. Scores range from 0 to 10.
  3. The scale has good reliability, with an overall Cronbach's α of .93.
  4. Subscale Cronbach's α values range from .77 to .93.
  5. The scale also has good test-retest reliability, with Pearson's r = .86, p < .01.
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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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