The Comparison of Self-care Status in Type Two Diabetic Patients Receiving versus not Receiving the Web-based Iranian Diabetic Personal Health Record System
This study is a randomized control trial which will be conducted aiming at examining the impact of web-based Diabetic Personal Health Record system on self-care status of diabetic patients compared with control arm. Inclusion criteria are type two diabetic patients aged between 20-70 who live in the Mashhad city and undergo at least one year of the disease. Also, they must be computer literate and have access to the internet and must provide informed consent. The patients will be randomly sampled from one private practice unit. In this study, the trial phase and blinding are not applicable. The sample size is 66 people that randomly will be assigned to control and intervention groups. The patients in intervention group will be allowed access to the web-based Diabetic Personal Health Record system while those in the control group will receive no intervention for four months. The study outcome measures include self-care status of patients, visit adherence, and drug adherence.
General information
Acronym
DPHR=Diabetic Personal Health Record
IRCT registration information
IRCT registration number:IRCT2013082914522N1
Registration date:2015-10-10, 1394/07/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-10, 1394/07/18
Registrant information
Name
Amirabbas Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2429
Email address
aziziaa901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study is the PhD dissertation in which has been supported by a grant from vice chancellor for research, Mashhad University of Medical Sciences [grant # 921835]
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Self-care Status in Type Two Diabetic Patients Receiving versus not Receiving the Web-based Iranian Diabetic Personal Health Record System
Public title
The Study on the Effect of Web-based Iranian Diabetic Personal Health Record System
Purpose
Health service research
Inclusion/Exclusion criteria
The inclusion criteria: Patient can be a male or female with type two diabetes; presence of diabetes type two at least for one year; aged between 20-70 years; be able to understand the consent content; must live in the city of Mashhad; must be computer literate and have access to the internet; must be in perfect health condition at the moment; must provide informed consent
The exclusion criteria: Already participating in another ongoing experimental research; pregnancy and lactation
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomization process will be done by the person who has no direct involvement in this trial. Also, the random allocation sequence will be done through computerized random number program.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the Regional Ethics Committee-vice chancellor for research, Mashhad University of Medical Sciences
Street address
Daneshgah Street-Qoreshi House-Mashhad
City
Mashhad
Postal code
۳۴۵ - ۹۱۳۷۵
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
research/921835/1/787
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self-care status
Timepoint
Baseline-Intermediate (two months after intervention)-immediately after end of intervention
Method of measurement
Summary of Diabetes Self-care Activities Measure-revised
Secondary outcomes
1
Description
medication adherence
Timepoint
one month after intervention-two months after intervention-three months after intervention-immediately after end of intervention
Method of measurement
the Morisky Medication Adherence Scale (MMAS-8)
2
Description
Visit appointment adherence
Timepoint
one month after intervention-two months after intervention-three months after intervention-immediately after end of intervention
Method of measurement
web-based Diabetic Personal Health Record system log
Intervention groups
1
Description
Intervention 1: the type two diabetic patients, that refer to the private practice unit, randomized to intervention arm will receive the web-based Diabetic Personal Health Record System for four months.
Category
Other
2
Description
Intervention 2: the type two diabetic patients, that refer to the private practice unit, randomized to control arm will not receive no intervention and will be followed for four months.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Private practice unit
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah Street-Qoreshi House-Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Position
Assistant professor, Department of Medical Informatics/Research affairs manager
Other areas of specialty/work
Street address
Department of Medical Informatics, School of Medicine, Park Square, Pardis Daneshgah, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3845 1521
Fax
Email
EslamiS@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Sayed Mahmood Tara
Position
Assistant professor, Department of Medical Informatics
Other areas of specialty/work
Street address
Department of Medical Informatics, School of Medicine, Park Square, Pardis Daneshgah, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3800 2429
Fax
Email
Taram@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirabbas Azizi
Position
PhD Candidate, Department of Medical Informatics
Other areas of specialty/work
Street address
Department of Medical Informatics, School of Medicine, Park Square, Pardis Daneshgah, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3800 2429
Fax
Email
aziziaa901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)