Self-care Management Programme for Type 2 Adult DM Patients With Poor Glycemic Control

NCT04092023 | Completed DMC

• 1 other identifier: ChanCY_RP1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes becomes the most prevalence chronic disease worldwide. Most type 2 diabetes patient are under the care in public general out-patient clinic in Hong Kong. The chronic nature of diabetic and the complexity of its management, on top of medication, diabetic patients often require behaviour modification and self-care management support. Effective diabetes self-care management education with patient-centered care approach with patients' participation and engagement has been shown to improve the clinical outcome. But such application during doctors' consultation are minimal in view of time limitation. Primary Care Nurse (PCN) is the first contact and is easily accessible in GOPCs. With support and training, PCN could act as a case manager to deliver the coordinated care. Interact and engage type 2 diabetes patients in self-care management, and work with multidisciplinary team in providing patient-centered care in GOPC setting. As there is lack of evidence about adopting such approach in the investigator's local population. This study is to test the effectiveness of the PCN led self-care management program to improve patients' clinical outcomes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Blood test for HbA1c

  Assess change from Baseline HbA1c at 6 months

Secondary Outcomes (3)

• Diabetes Knowledge

  Assess change from Baseline HbA1c at 6 months

• Self-Efficacy: Diabetes Empowerment Scale - Short Form (C-DES-SF)

  Assess change from Baseline HbA1c at 6 months

• QOL: Audit of Diabetes Dependent Quality of Life (ADDQoL-19)

  Assess change from Baseline HbA1c at 6 months

Study Arms (2)

Control group

OTHER

Participants in control group will be received usual care. They will be gone through yearly DM complication screening. A screening report and information sheet on general DM management will be issued to participants. Therapeutic goals will be set and further conventional health care education intervention will be referred.

Other: nursing education

Intervention group

OTHER

The interventions are designed to address the seven key self-management behaviours identified by the Association of American Diabetes Educations: (1) healthy eating, (2) being active, (3) monitoring, (4) taking medication, (5) problem solving, (6) reducing risk, and (7) healthy coping. In addition, the Chronic Care Model elements of self-management support and patient centered-care approach is embraced during the intervention process. The nursing care components provided to participants will be included (a) self-care management knowledge, (b) skill-based learning and problem solving, (c) participants' participation and engagement, (d) participants' in goal setting, and (e) coordinate care, involve participants to make decision.

Other: nursing education

Interventions

nursing education OTHER

Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes. Two subsequent phones follow up to participants will be arranged.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>=18
• Clinically diagnosed of type 2 diabetes
• Poorly glycemic control with recent HbA1c ≧ 7.5%
• Chinese participants who could speak Cantonese

You may not qualify if:

• Unable to perform self-care management due to physical or mental limitation
• Engage in another similar program
• Pregnancy
• Life expectancy \<1 year due to malignancies or other terminal illness

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

KWC FM & PHC, Hospital Authority

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nursing Education Research

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nursing Research; Nursing Process; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ching Y Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A six month and two-arm parallel randomized control trial is employed

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 17, 2019
• Study Start: October 2, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become availiable in 1Q 2021 and starting 6 months after publication
• Access Criteria: Principle investigator will review requests

Locations

HK (1)