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The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients

1. november 2022 opdateret af: Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Indonesia University

Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes

In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c <7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching.

Education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach.

Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indonesien
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesien, 10430
        • Faculty of Medicine, Universitas Indonesia

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 til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • T2DM patients
  • aged 30-60 years old
  • HbA1C > 7.5% within the past 3 months
  • able to write and read.

Exclusion Criteria:

  • Patients with cognitive disease (such as dementia)
  • having hearing problem or sight problem
  • unable to live independently on daily basis
  • having disease that may affect HbA1c result (eg: hemolytic anemia)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Conventional Education Class
Eksperimentel: Coaching
Health Coaching
Andet: Health Coaching
Health Coaching as face to face with a coach

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline HbA1c at 3 months
Tidsramme: 3 month after intervention
Glycemic Control
3 month after intervention
Change from Baseline HbA1c at 6 months
Tidsramme: 6 month after intervention
Glycemic Control
6 month after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Fasting Plasma Glucose at 3 months
Tidsramme: 3 month after intervention
Glycemic Control
3 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 3 months
Tidsramme: 3 months after intervention
Glycemic control
3 months after intervention
Change from HDL-cholesterol at 3 months
Tidsramme: 3 months after intervention
Diabetes mellitus control
3 months after intervention
Change from LDL-cholesterol at 3 months
Tidsramme: 3 months after intervention
Diabetes mellitus control
3 months after intervention
Change from Triglycerides at 3 months
Tidsramme: 3 months after intervention
diabetes mellitus control
3 months after intervention
Change from Total Cholesterol at 3 months
Tidsramme: 3 months after intervention
Diabetes mellitus control
3 months after intervention
Change of Body mass index at 3 months
Tidsramme: 3 month after intervention
Diabetes mellitus control
3 month after intervention
Change calorie intake at 3 months
Tidsramme: 3 month after intervention
life style parameter
3 month after intervention
International Physical Activity Questionnaire (IPAQ) questionnaire
Tidsramme: baseline, 3 month and 6 months after intervention
consist of several question about activities in the whole week. Scoring divided into 3 categories : low, moderate, high. This questionnaire is to describe activities no to divided whether high score means good or bad
baseline, 3 month and 6 months after intervention
EQ-5D quality of life questionnaire
Tidsramme: baseline, 3 month and 6 months after intervention
This questionnaire consist of several question with 5 main outcome mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Subjects will answer the question with fully, half or none.
baseline, 3 month and 6 months after intervention
Change from Baseline Fasting Plasma Glucose at 6 months
Tidsramme: 6 month after intervention
Glycemic Control
6 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 6 months
Tidsramme: 6 months after intervention
Glycemic Control
6 months after intervention
Change from HDL-cholesterol at 6 months
Tidsramme: 6 months after intervention
diabetes mellitus Control
6 months after intervention
Change from LDL-cholesterol at 6 months
Tidsramme: 6 months after intervention
diabetes mellitus Control
6 months after intervention
Change from Triglycerides at 6 months
Tidsramme: 6 months after intervention
diabetes mellitus Control
6 months after intervention
Change from Total Cholesterol at 6 months
Tidsramme: 6 months after intervention
diabetes mellitus Control
6 months after intervention
Change from systolic and diastolic blood pressure at 6 months
Tidsramme: 6 months after intervention
diabetes mellitus Control
6 months after intervention
Change calorie intake at 6 months
Tidsramme: 6 months after intervention
life style parameter
6 months after intervention
Change of Body mass index at 6 months
Tidsramme: 6 months after intervention
diabetes mellitus control
6 months after intervention

Samarbejdspartnere og efterforskere

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

Sponsor

Indonesia University

Efterforskere

  • Ledende efterforsker: Pradana Soewondo, Prof, Fakultas Kedokteran Universitas Indonesia

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 (Faktiske)

1. februar 2018

Primær færdiggørelse (Faktiske)

31. august 2018

Studieafslutning (Faktiske)

31. marts 2020

Datoer for studieregistrering

Først indsendt

10. februar 2020

Først indsendt, der opfyldte QC-kriterier

27. februar 2020

Først opslået (Faktiske)

28. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PS002

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Diabetes type 2

Kliniske forsøg med Health Coaching

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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