The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
1. november 2022 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Faculty of Medicine, Universitas Indonesia
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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
30 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control
Conventional Education Class
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Eksperimentell: Coaching
Health Coaching
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Health Coaching as face to face with a coach
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Glycemic Control
|
6 month after intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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Change from HDL-cholesterol at 3 months
Tidsramme: 3 months after intervention
|
Diabetes mellitus control
|
3 months after intervention
|
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Change from LDL-cholesterol at 3 months
Tidsramme: 3 months after intervention
|
Diabetes mellitus control
|
3 months after intervention
|
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Change from Triglycerides at 3 months
Tidsramme: 3 months after intervention
|
diabetes mellitus control
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3 months after intervention
|
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Change from Total Cholesterol at 3 months
Tidsramme: 3 months after intervention
|
Diabetes mellitus control
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3 months after intervention
|
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Change of Body mass index at 3 months
Tidsramme: 3 month after intervention
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Diabetes mellitus control
|
3 month after intervention
|
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Change calorie intake at 3 months
Tidsramme: 3 month after intervention
|
life style parameter
|
3 month after intervention
|
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International Physical Activity Questionnaire (IPAQ) questionnaire
Tidsramme: baseline, 3 month and 6 months after intervention
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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
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baseline, 3 month and 6 months after intervention
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EQ-5D quality of life questionnaire
Tidsramme: baseline, 3 month and 6 months after intervention
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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.
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baseline, 3 month and 6 months after intervention
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Change from Baseline Fasting Plasma Glucose at 6 months
Tidsramme: 6 month after intervention
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Glycemic Control
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pradana Soewondo, Prof, Fakultas Kedokteran Universitas Indonesia
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 (Faktiske)
1. februar 2018
Primær fullføring (Faktiske)
31. august 2018
Studiet fullført (Faktiske)
31. mars 2020
Datoer for studieregistrering
Først innsendt
10. februar 2020
Først innsendt som oppfylte QC-kriteriene
27. februar 2020
Først lagt ut (Faktiske)
28. februar 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. november 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. november 2022
Sist bekreftet
1. november 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PS002
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