Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

13 aprile 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

152

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Hong Kong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong, Hong Kong
        • Reclutamento
        • Clinics of private general practitioners
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altro: 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
Nessun intervento: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glycated haemoglobin (HbA1c)
Lasso di tempo: Change from Baseline HbA1c at week 20
Glycemic control
Change from Baseline HbA1c at week 20
Self-efficacy level in diabetes management
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diabetes Empowerment Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chinese University of Hong Kong

Collaboratori

Association of Hong Kong Nursing Staff

Investigatori

  • Investigatore principale: Hau Yee H CHUNG, Chinese University of Hong Kong

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2019

Completamento primario (Anticipato)

31 dicembre 2020

Completamento dello studio (Anticipato)

31 marzo 2021

Date di iscrizione allo studio

Primo inviato

5 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

13 aprile 2020

Primo Inserito (Effettivo)

16 aprile 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CREC2019.290
  • Clinical Research Ethics (Altro identificatore: Joint CUHK-NTEC CREC)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Diabetes Care Programme

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Ukraine

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi