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Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care (EDDMQoL-Pro)

9. oktober 2018 opdateret af: Boon-How Chew, Universiti Putra Malaysia

Relationship Between Emotional Disorders (Diabetes Distress and Depression) and Outcomes (Self-care and Clinical) in Adults With Type 2 Diabetes Mellitus in Primary Care: A Retrospective Cohort Study

This study aims to determine which factors are related to change in diabetes-related distress and change in depressive symptoms after three years of follow-up in Asian adults with type 2 diabetes mellitus in primary care. The investigators will explore the impact of patient demographics, cardiometabolic control, medications adherence, health-related quality of life, self-efficacy and self-management behaviors on diabetes-related distress and depressive symptoms.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients with type 2 diabetes mellitus (T2DM) have been shown to experience psychological burden and distorted illness perception. These psychological burden include feeling of burned-out, fatigue, distress and depression, and in addition of distorted illness perception often lead to difficulty in coping with the demands of life-style changes and adherence to medication. Diabetes-related distress (DRD) and depressive symptoms (DS) were associated with glycaemic control and medication adherence, and life-styles behaviors, respectively. However, evidence on the relationships between DRD, DS and clinically significant outcomes are scarce in Asian adults with T2DM. Primary care patients who participated before will be re-invited. This is a repeated cross-sectional study of a cohorts of 700 patients who were first studied in 2013 (Emotional Distress in adults with type 2 Diabetes Mellitus & Quality of Life [EDDMQoL] study with the National Medical Research Register (NMRR) identification number: NMRR-12-1167-14158). Demographic data (age, gender, ethnicity, religion, educational level, occupation and monthly income), smoking status, self-perceive social support and health literacy will be collected by questionnaires.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

336

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

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who participated before in the EDDMQoL in 2013 (NMRR ID: NMRR-12-1167-14158)

Beskrivelse

Inclusion Criteria:

  1. Those who participated in the EDDMQoL study
  2. Adults aged at least 30 year-old
  3. Diagnosed of T2DM more than three years ago
  4. On regular follow-up with at least three visits in the previous year

Exclusion Criteria:

  1. Patients who are pregnant or lactating
  2. Having psychiatric/psychological disorders that could impair judgments and memory
  3. Patients who cannot read or understand English, Malay or Mandarin

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diabetes-related distress measured with Diabetes Distress Scale-17
Tidsramme: Baseline and 3 year
Change in diabetes-related distress
Baseline and 3 year
Depressive symptoms measured with Patient Health Questionnaire-9
Tidsramme: Baseline and 3 year
Change in depressive symptoms
Baseline and 3 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diabetes-related distress and depression combined
Tidsramme: Baseline and 3 year
Change in both diabetes-related distress and depressive symptoms combined
Baseline and 3 year
Illness perceptions measured with Brief Illness Perception Questionnaire
Tidsramme: Through study completion
Cross-sectional, an association with other variables
Through study completion
Diabetes distress measured with Problem Areas in Diabetes Scale (PAID-5)
Tidsramme: Through study completion
Cross-sectional, an association with other variables
Through study completion

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Variability in HbA1c
Tidsramme: Baseline and 3-year
Standard deviations of the HbA1c from the medical records
Baseline and 3-year
Variability in systolic blood pressure
Tidsramme: Baseline and 3-year
Standard deviations of the systolic blood pressures from the medical records
Baseline and 3-year
Variability in pulse rates
Tidsramme: Baseline and 3-year
Standard deviations of the pulse rates from the medical records
Baseline and 3-year
Health care utilisation/hospitalisation
Tidsramme: 3-year
Retrospective records of the number of visits to healthcare facilities and hospitalisation from the medical records
3-year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universiti Putra Malaysia

Samarbejdspartnere

UMC Utrecht
Ministry of Health, Malaysia

Efterforskere

  • Ledende efterforsker: Boon How Chew, MMed, Universiti Putra Malaysia

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.

Generelle publikationer

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 2016

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

29. marts 2016

Først indsendt, der opfyldte QC-kriterier

31. marts 2016

Først opslået (Skøn)

6. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NMRR-15-2214-28139

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymous data will be made available in figshare

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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