Effect of Personalized Feedback Report and Peer Support on Diabetes

Diabetes Clinical Trial

Official title:

A Quality Improvement Project Evaluating the Effect of Regular Personalized Feedback Report and Peer Support for Patients With Diabetes in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199834
• Other study ID #: CRE-2013.033
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: December 21, 2015
• Start date: February 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In this project, the investigators hypothesize that in an integrated, multifaceted, team-based program incorporating comprehensive assessment with risk stratification, diabetic patients with high risk of negative emotions and hospitalization will benefit from additional peer support which will improve their psychological health, cardio-metabolic control, self-management, quality of life and reduce hospitalization. The investigators further hypothesize that peer support will interact with regular personalized feedback reporting to improve clinical outcomes.

Description:

Diabetes self-management is often emotionally and physically taxing, demanding lifelong commitment to medication adherence and lifestyle modification. People with diabetes have to be well-educated and supported to make clinical decisions in their daily living. However, most diabetes self-management education (DSME) interventions are short-term and have little external support. In order to empower patients to self-manage over a lifetime after the initial DSME, ongoing multidisciplinary programs which coordinates individual components of care into a structured system and further supported by reinforcement through multiple contacts are necessary to provide practical tips as well as social and psychological support to diabetic patients, so as to sustain behavioral changes and improve metabolic control.

Based on these principles, the Joint Asia Diabetes Evaluation (JADE) Program was developed in 2007 as a quality improvement initiative to deliver technologically integrated and multidisciplinary team-based care. It is enabled by a web-based portal containing templates which guide care providers in providing standardized comprehensive assessments, the results of which are then used for personalized risk stratification and feedback reports. The personalized feedback report contains the patient's risk category according to the JADE definition, with visual displays of important trends including those of glycated haemoglobin (HbA1c), blood pressure (BP), low-density-lipoprotein-cholesterol (LDL-C), and body mass index (BMI), and practical suggestions to help the individual to reach multiple treatment targets based on the latest values.

On the other hand, according to a recent WHO consultation report, peer support intervention is considered to have enormous potential to improve self-management in patients with chronic disease. Programs using peer supporters to teach and support their peers with diabetes have shown significant reductions in HbA1c, enhanced self-efficacy, improved health status and better self-management behaviors. In our previous study, we found that a combined program which integrates structured care, peer support and clinical decision support by regular follow up report significantly improved psychological health and medication adherence of diabetic patients, and reduced hospitalization of patients with negative emotions like depression, distress, and anxiety, who were most likely to suffer from chronic kidney disease or poor glycemic control. In this program, we hypothesize that using a multifaceted program which incorporates structured care, personalized feedback reporting, and peer support to influence and motivate diabetic patients with high risk of hospitalization and negative emotions on diabetes self-management, will further improve their self-management, psychological health and metabolic control, and reduce hospitalization. We further hypothesize that receiving personalized feedback report with decision support will improve glycemic control and reduce hospitalization in patients with diabetes.

Around 286 patients with high risk of negative emotion and hospitalization will be invited to join the peer support program. We anticipate that half of the patients will agree (n=143) and be assigned 24 peer supporters on a 5~6:1 ratio. Peer supporters are patients who have good glycemic control and self-care and trained to provide both informational and emotional support to the peer group. For patients who decline to participate, they will be identified as refused peer group and their reasons for declining will be documented. Half of the patients in each group will be randomized to receive 2 personalized feedback reports through the mail.

1200 adult patients consecutively enrolled in JADE program will be recruited and half of them (n=600) will be randomized to receive a personalized feedback report twice a year. All patients will be followed up at their usual clinics and will be observed for at least 1 year when we shall evaluate the effects of providing regular personalized report on clinical outcomes including metabolic control and hospitalization.

To evaluate the independent effects of peer support , we further used a case-control design to. Within the 1200 patients who were not offered peer support, a group of patients who met the criteria of "high risk" were matched to those agreed to receive peer support on a 3:1 basis by age, gender, diabetes duration, and baseline HbA1c as a control group. Data of metabolic control and hospitalization of the control group were retrieved from the CMS and compared to that of the peer group after 1 year.

The study objectives are:

1. To study the effect of regular personalized feedback reports to patients with diabetes managed within an integrated care program on hospitalization and metabolic control, irrespective of their risk levels.

2. To study the feasibility of using trained diabetes patients (peer supporters) to assist diabetes educators in diabetes management.

3. To study the acceptability of peer support in a real life setting and the effects of non-participation in peer support program on clinical outcomes including hospitalization and glycemic control in high risk patients for negative emotions and multiple risk factors.

4. To study the independent and interactive effects of peer support and regular personalized feedback report on cardio-metabolic risk factor control, psychological health, self-efficacy, self-management, quality of life and hospitalization rates in patients with diabetes at high risk for negative emotions and multiple risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1488
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

For peer supporters:

• Patients with type 2 diabetes.

• Aged between 18 and 75 years (inclusive).

• Chinese ethnicity.

• Stable glycemic control (HbA1c<7.5%) and self-rated health status=80 as assessed by EQ5D visual scale.

• Enthusiastic and willing to become peer supporters.

For peers:

• Patients with diabetes.

• Aged between 18 and 75 years (inclusive).

• Chinese ethnicity.

• At least 1 of the following risk factors: HbA1c?8%/ BMI?27.5 kg/m2/ Waist circumstance?80cm in women or ?90cm in men/ Chronic kidney disease (CKD) defined as estimated glomerular filtration rate less than 60 ml/min /1.73m2.

• Agree to receive peer support

For report group and usual care group:

• All Chinese diabetes patients between 18-75 years of age who undergo comprehensive assessment and join the JADE program.

Exclusion Criteria:

For peer supporters:

• HbA1c?7.5% in last 6 months.

• Terminal malignancy or other life-threatening diseases.

• Unstable mental diseases.

• Unable to communicate in Chinese.

For peers:

• Terminal malignancy or other life-threatening diseases.

• Unstable mental illness.

• Unable to communicate in Chinese.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Peer support
15 patients who have good glycemic control and self-care will be trained as peer supporters to deliver peer support under supervision by a program manager. Peer supporters will call their peers at least 12 times a year to provide both informational and emotional support.
• Personalized feedback report
Patients will receive a personalized feedback report displaying trends of metabolic control of A1c, BP, LDL-C, and body weight, with automated decision support based on their own attained values every 4 months through mails.

Locations

Country	Name	City	State
China	Prince of Wales Hospital, Chinese University of Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization	The number of, and the corresponding reasons for hospital admissions, using the International Classification of Diseases-9th version in the discharge summary, retrieved from the Hong Kong Hospital Authority Central Computer System.	12 months	No
Primary	Change of HbA1c		12 months	No
Secondary	Changes in self-efficacy	Diabetes Empowerment Scale (DES)	12 months	No
Secondary	Change in cardio-metabolic risk factors	Absolute change in risk factors (A1c, LDL-C, body weight, blood pressure)	12 months	No
Secondary	Clinically meaningful reductions in risk factors	Percentage of patients with clinically meaningful reductions in risk factors (A1c >=0.5%; LDL-C>=30%; systolic BP>=10 mmHg and body weight>=3% compared with baseline)	12 months	No
Secondary	Percentage of patients attaining multiple treatment goals	Percentage of patients attaining multiple treatment goals (A1c <7%, LDL-C<2.6 mmol/L and BP<130/80 mmHg).	12 months	No
Secondary	Satisfaction survey by participants	Satisfaction survey by peers	12 months	No
Secondary	Change in negative emotions	Depression Anxiety Stress Scale-21 (DASS21)	12 months	No
Secondary	Change in quality of life	WHO Quality of Life-Bref (WHOQOL-BREF),	12 months	No
Secondary	Change in health-related quality of life	Euro Quality of Life (EQ5D)	12 months	No
Secondary	Change in depressive symptom	Patient Health Questionnaire (PHQ9).	12 months	No