Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00454

2 Trial Registration Date

2015-05-29

i Registration Status

Prospective

3 Secondary IDs

2015.081-T

4 Source(s) of Funding

The Nethersole School of Nursing, The Chinese University of Hong Kong

5 Primary Sponsor

Prof. Eliza Mi-Ling Wong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof. Eliza Mi-Ling Wong

ii Address

Rm 828, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

3943 8098

iv Email

elizawong@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Eliza Mi-Ling Wong

ii Address

Rm 828, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

3943 8098

iv Email

elizawong@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing

vi Country

9 Official Scientific Title of the Study

Usability and the effect of an e-health mobile app on health behavior and glycemic control for Diabetes Mellitus (DM) clients

10 Public Title

Usability and the effect of an e-health mobile app on glycemic control for Diabetes Mellitus (DM) clients

i Public Title in Chinese 研究名稱

手機程式對糖尿病人的血糖控制及改善健康行為的效用及可行性

11 Short Title (Optional)

Usability and the effect of an e-health mobile app on glycemic control for Diabetes Mellitus (DM) clients

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-04-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Diabetes Mellitus

15 Intervention

i Types of intervention

Other

Please specify

Mobile apps

ii Description/ name of Intervention/article

The e-health mobile apps is an applications that can be installed on smart phone. The mobile apps provide a safe, individualized, interactive platform where members can input, view and retrieve their own blood sugar, exercise records, health measures daily.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Usual care: general briefing of DM care by nurse, follow-up by physicians.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Ethnic Chinese adult who attends regular follow-up treatments for their DM problems, can read and communicate in Chinese, can use and access Internet at home and willing to participate.

ii Exclusion Criteria

Patients with physical, mental, visual or cognitive impairments, as recorded in their health records, and those who have contra-indications to walking will be excluded from the study.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-06-15

21 Target Sample Size

448

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

HbA1c level (at baseline, 3 months, 6 months)

24 Secondary Outcome

Diabetes self-care activities and self-management; Chronic disease self-management program questionnaire; Diabetes management self-efficacy scale; exercise efficacy; exercise adherence; DM physical parameters and complications (e.g. BP, BMI, lipid profile, DM complications); psychological health outcomes [all above mentioned will be evaluate at baseline, 3 months and 6 months)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-05-29

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-15006471

28 Date of Registration in Primary Registry

2015-05-31

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2015-07-10