NCT02199834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,488

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

July 22, 2014

Last Update Submit

December 21, 2015

Conditions

Diabetes

Keywords

diabetespeer supportpersonalized feedback report

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change of HbA1c

    12 months

Secondary Outcomes (9)

  • Changes in self-efficacy

    12 months

  • Change in cardio-metabolic risk factors

    12 months

  • Clinically meaningful reductions in risk factors

    12 months

  • Percentage of patients attaining multiple treatment goals

    12 months

  • Satisfaction survey by participants

    12 months

  • +4 more secondary outcomes

Study Arms (4)

Peer group

EXPERIMENTAL

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 supportBehavioral: Personalized feedback report

Refused peer group

OTHER

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

Report group

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Peer supportBEHAVIORAL

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.

Peer group
Personalized feedback reportBEHAVIORAL

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.

Peer groupRefused peer groupReport group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong SAR, 999077, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Junmei YIN, MPH

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 25, 2014

Study Start

February 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

CN(1)