Protocol summary

Study aim
Development and evaluation a theory-based intervention for improving medication and diet adherence in Patients with Type 2 Diabetes
Design
randomised trial with control group ,without blinded, design for 248 patients, Randomised
Settings and conduct
Patients with diabetes referred to the health centers of the South under the cover of Tehran University of Medical Sciences The study will be done in two phases. The intervention phase of the study includes the allocation of the target group in two groups of intervention and control, which In the intervention group will be done the educational intervention.
Participants/Inclusion and exclusion criteria
Younger than 65 years Patients with diabetes referred to the health centers of the South under the cover of Tehran University of Medical Sciences whose disease has been confirmed by doctors. Diagnosed with type 2 diabetes for more than six months. They have Score of medication and diet adherence low. To be satisfied with the study.
Intervention groups
The intervention group are patients with type 2 diabetes to receive theory-based educational interventions for improve diet and medication adherence
Main outcome variables
the improving medication and diet adherence in Patients with Type 2 Diabetes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151208025431N4
Registration date: 2018-03-10, 1396/12/19
Registration timing: prospective

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Elham Shakibazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3210
Email address
shakib@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and evaluation a theory-based intervention for medication and diet adherence in Patients with Type 2 Diabetes
Public title
Effect of intervention on adherence in Diabetics
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Younger than 65 years Patients with diabetes referred to the health centers of the South under the cover of Tehran University of Medical Sciences whose disease has been confirmed by doctors. Diagnosed with type 2 diabetes for more than six months. They have Score of medication and diet adherence low. To be satisfied with the study.
Exclusion criteria:
Age
To 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 248
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization stratified randomization Lottery
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
IR.TUMS.SPH.REC.1396.4200

Health conditions studied

1

Description of health condition studied
type 2 diabet
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Adherence scale of medication
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the intervention
Method of measurement
Morisky questionaire

2

Description
Adherence scale of diet
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the intervention
Method of measurement
questionaire

Secondary outcomes

1

Description
Task selfefficacy
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

2

Description
Intention
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

3

Description
Action planning
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

4

Description
coping planning
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

5

Description
Coping selfefficacy
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

6

Description
Recovery selfefficacy
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

7

Description
Perceived social support
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 1, 6 months after the interven
Method of measurement
questionaire

8

Description
HbA1C
Timepoint
Adherence measurement at the beginning of the study (before the intervention) and 6 months after the interven
Method of measurement
HbA1C

Intervention groups

1

Description
Intervention group: Theory-based interventions based on HAPA and needs assessment baseline
Category
N/A

2

Description
Control group: The control group will not intervene and only HbA1c Test were measured baseline and 6 months after the intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
South Tehran Health Centers
Full name of responsible person
dr. Ghayumzadeh
Street address
No. 2, Alley, Shahid Abbas Shafiee,Vesal SHirazi Ave, Engelab Ave
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 6695 0069
Email
Gayumzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeiyan
Street address
Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
name@domian.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
School of Public Health, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheila Ranjbaran
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health,Poursina Street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Email
sph@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Eelham Shakibazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Email
shakibazadeh@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheila Ranjbaran
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Email
s-ranjbaran@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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