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Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting

13. april 2020 opdateret af: Hau Yee CHUNG, Chinese University of Hong Kong

An Evaluation of the Effect of a Diabetes Care Programme for People With Type 2 Diabetes Mellitus in Primary Care Setting: A Randomized Controlled Trial

Uncontrolled metabolic parameters and co-morbidity risk factors cause Diabetes Mellitus as the leading cause of a multitude of micro-/macro-vascular complications. According to the International Guidelines and Recommendations, people with Type 2 Diabetes Mellitus (T2DM) should attend diabetes educational programmes periodically and optimize the metabolic index of control. In Hong Kong, General Practitioners with solo-practice (GP-SP) have the least availability of resources and support in DM management. A discrepancy of diabetes care between public and private settings and a gap of clinical practice between public-private healthcare settings is identified. In relation to the big population of T2DM is caring by GP-SP but no structured Diabetes Care Programme (DCP) is in place. A structured DCP for T2DM is in need to fill up the clinical gap and make beneficial to the target subjects.

The aim of this study is to evaluate the effectiveness of a DCP for people with T2DM in primary care settings. It is a multi-center, single-blind randomized controlled trial with parallel groups pre-test and post-test design. The evidence-based intervention (DCP) will be carried out in a private primary care setting. People with T2DM attending the GP-SP who meet the study criteria will be randomly assigned into one of the two study groups, either "DCP in addition to usual medical care" or "Usual medical care only" as a control group. The intervention group can beneficial in clinical and psychosocial outcomes after the completion of the 20-week structured DCP with a greater improvement of HbA1c level, Self-Efficacy in diabetes management, Diabetes Empowerment level, Diabetes Knowledge, and Quality of Life than those who only received usual medical care at the GP-SP.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is to implement an evidence-based develop Diabetes Care Programme (DCP) for 152 adults with Type 2 Diabetes Mellitus (T2DM) in a few clinics of a general practitioner with solo-practice (GP-SP) in community, and evaluate its effectiveness by comparing the outcomes between study group (DCP with the usual medical care) and control group (Usual medical care only). It is believed that a structured DCP can promote greater clinical outcomes improvement and behavioral changes in the study group as evidence showed in literature. The primary outcomes are glycemic control (HbA1c level) and Self-Efficacy in diabetes management; whereas Diabetes Empowerment level, Diabetes Knowledge and Quality of Life are the secondary outcomes.

The DCP consists of two parts, conduct 3 interactive group education with an innovative educational tool "Diabetes Conversation Map™" sessions by dietitian and diabetes educator/nurse. Then it followed by another 8 weeks for delivering two 15-30 minutes teleconsultations for patient empowerment and follow-up of "Action Plan" by a diabetes educator/nurse. Evaluation of outcomes will be done before the DCP (baseline), at week-8 (right after the group sessions), and at week-20 (4 weeks after the last teleconsultation).

In addition, a focus group interview will be carried out after the completion of the whole intervention. It purposes to explore and get valuable descriptive information and feelings from participants about the intervention and diabetes self-management.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Hong Kong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong, Hong Kong
        • Rekruttering
        • Clinics of private general practitioners
        • Kontakt:

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. People with T2DM and follow up at private general practitioner
  2. Age 18-75
  3. Haemoglobin A1c (HbA1c) >7.0%
  4. Can communicate in Cantonese

Exclusion Criteria:

  1. Insulin users
  2. Unstable emotional and/or mental status
  3. Cognitive impairment and/or learning disabilities
  4. Recruited in other research and/or diabetes educational programme during the study period

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diabetes Care Programme
People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who receive the intervention (Diabetes Care Programme) in addition to usual medical care at the GP
Andet: Diabetes Care Programme
20-week Diabetes Care Programme consists of three Diabetes Conversation Map sessions in 8 weeks with 3-4 weeks intervals, then two teleconsultations at week 12th and week 16th
Ingen indgriben: Standard Usual Care
People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who only receive the usual medical care at the GP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycated haemoglobin (HbA1c)
Tidsramme: Change from Baseline HbA1c at week 20
Glycemic control
Change from Baseline HbA1c at week 20
Self-efficacy level in diabetes management
Tidsramme: Change from Baseline Self-efficacy level at week 8
To assess the Self-efficacy level in diabetes management of Chinese people with diabetes. Includes 20 items of self-care in six domains with 1-10 rating scale. Higher score means better self-care.
Change from Baseline Self-efficacy level at week 8
Self-efficacy level in diabetes management
Tidsramme: Change from Baseline Self-efficacy level at week 20
To assess the Self-efficacy level in diabetes management of Chinese people with diabetes. Includes 20 items of self-care in six domains with 1-10 rating scale. Higher score means better self-care.
Change from Baseline Self-efficacy level at week 20

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diabetes Empowerment Scale
Tidsramme: Change from Baseline Psycho-social Self-efficacy level at week 8
To assess the overall psycho-social self-efficacy level of Chinese people with diabetes. It includes 10 items with a 1-5 rating scale. A higher score means a higher level of self-efficacy.
Change from Baseline Psycho-social Self-efficacy level at week 8
Diabetes Empowerment Scale
Tidsramme: Change from Baseline Psycho-social Self-efficacy level at week 20
To assess the overall psycho-social self-efficacy level of Chinese people with diabetes. It includes 10 items with a 1-5 rating scale. A higher score means a higher level of self-efficacy.
Change from Baseline Psycho-social Self-efficacy level at week 20
Diabetes Knowledge Questionnaire
Tidsramme: Change from Baseline Diabetes self-care knowledge at week 8
To assess the Diabetes self-care knowledge of Chinese people with diabetes. It includes 24 items of diabetes self-care knowledge with the total score range from 0-24. Valid responses with "yes", "no" or "I don't know"; only scored on correct answers. A higher score means a higher level of diabetes knowledge.
Change from Baseline Diabetes self-care knowledge at week 8
Diabetes Knowledge Questionnaire
Tidsramme: Change from Baseline Diabetes self-care knowledge at week 20
To assess the Diabetes self-care knowledge of Chinese people with diabetes. It includes 24 items of diabetes self-care knowledge with the total score range from 0-24. Valid responses with "yes", "no" or "I don't know"; only scored on correct answers. A higher score means a higher level of diabetes knowledge.
Change from Baseline Diabetes self-care knowledge at week 20
Quality of life Measurement
Tidsramme: Change from Baseline Quality of Life status at week 8
The valuation of health status (quality of life) of Chinese people. It includes 5 health dimensions with a sum of negative validity & 1 visual analog scale to reflect the self-rated health score. A higher score means a higher quality of life status.
Change from Baseline Quality of Life status at week 8
Quality of life Measurement
Tidsramme: Change from Baseline Quality of Life status at week 20
The valuation of health status (quality of life) of Chinese people. It includes 5 health dimensions with a sum of negative validity & 1 visual analog scale to reflect the self-rated health score. A higher score means a higher quality of life status.
Change from Baseline Quality of Life status at week 20

Samarbejdspartnere og efterforskere

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

Sponsor

Chinese University of Hong Kong

Samarbejdspartnere

Association of Hong Kong Nursing Staff

Efterforskere

  • Ledende efterforsker: Hau Yee H CHUNG, Chinese University of Hong Kong

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. november 2019

Primær færdiggørelse (Forventet)

31. december 2020

Studieafslutning (Forventet)

31. marts 2021

Datoer for studieregistrering

Først indsendt

5. april 2020

Først indsendt, der opfyldte QC-kriterier

13. april 2020

Først opslået (Faktiske)

16. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CREC2019.290
  • Clinical Research Ethics (Anden identifikator: Joint CUHK-NTEC CREC)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med Diabetes Care Programme

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