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Effect of Personalized Feedback Report and Peer Support on Diabetes

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ClinicalTrials.gov Identifier: NCT02199834
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Junmei YIN, Chinese University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Peer support Behavioral: Personalized feedback report Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1488 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Quality Improvement Project Evaluating the Effect of Regular Personalized Feedback Report and Peer Support for Patients With Diabetes in Hong Kong
Study Start Date : February 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Peer group
24 patients who have good glycemic control and self-care will be trained as peer supporters to deliver peer support to this group 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. Half of the patients in this group will be randomized to 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.
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.

Behavioral: 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.

Refused peer group
Patients who fit the criteria of peers but refuse to be contacted by peer supporters will be signed as refused group. Half of the patients in this group will be randomized to 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.
Behavioral: 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.

Experimental: Report group
Patients in this group 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 twice a year through mails.
Behavioral: 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.

No Intervention: Usual care
Patients will receive standard usual care with clinicians' follow-up and referral with education to diabetes nurses if deemed necessary at in-charge clinicians' discretion.



Primary Outcome Measures :
  1. Hospitalization [ Time Frame: 12 months ]
    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.

  2. Change of HbA1c [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in self-efficacy [ Time Frame: 12 months ]
    Diabetes Empowerment Scale (DES)

  2. Change in cardio-metabolic risk factors [ Time Frame: 12 months ]
    Absolute change in risk factors (A1c, LDL-C, body weight, blood pressure)

  3. Clinically meaningful reductions in risk factors [ Time Frame: 12 months ]
    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)

  4. Percentage of patients attaining multiple treatment goals [ Time Frame: 12 months ]
    Percentage of patients attaining multiple treatment goals (A1c <7%, LDL-C<2.6 mmol/L and BP<130/80 mmHg).

  5. Satisfaction survey by participants [ Time Frame: 12 months ]
    Satisfaction survey by peers

  6. Change in negative emotions [ Time Frame: 12 months ]
    Depression Anxiety Stress Scale-21 (DASS21)

  7. Change in quality of life [ Time Frame: 12 months ]
    WHO Quality of Life-Bref (WHOQOL-BREF),

  8. Change in health-related quality of life [ Time Frame: 12 months ]
    Euro Quality of Life (EQ5D)

  9. Change in depressive symptom [ Time Frame: 12 months ]
    Patient Health Questionnaire (PHQ9).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199834


Locations
China
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong SAR, China, 999077
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Junmei YIN, MPH Chinese University of Hong Kong

Responsible Party: Junmei YIN, Ms., Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02199834     History of Changes
Other Study ID Numbers: CRE-2013.033
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Junmei YIN, Chinese University of Hong Kong:
diabetes
peer support
personalized feedback report

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases