Evaluating of a virtual educational-supportive intervention based on empowerment model on promoting treatment among patients with type 2 diabetes with limited health literacy
Design
This study will be conducted as a randomized controlled trial with parallel groups. At this stage, 264 participants will be randomly assigned to two intervention and comparison groups (132 people in each group) through random allocation by random quadruple block method from different centers. In this study, blinding has not been considered.
Settings and conduct
Study location will be governmental diabetes clinics in Kerman city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 30 years, limited health literacy, low adherence to treatment, at least 6 months have passed since diabetes diagnosis, willingness to participate in the study, the absence of approved psychological problems.
Exclusion criteria: Pregnant women with gestational diabetes, type 1 diabetes; underlying diseases not related to type 2 diabetes (such as cancers and autoimmune patients, etc.)
Intervention groups
Intervention group: Virtual educational supportive intervention based on an Empowerment Model. Control group: only the routine training of the centers.
Main outcome variables
Adherence to treatment and HbA1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210601051465N1
Registration date:2021-06-27, 1400/04/06
Registration timing:registered_while_recruiting
Last update:2021-06-27, 1400/04/06
Update count:0
Registration date
2021-06-27, 1400/04/06
Registrant information
Name
Nasrin Pourhabibi Zarandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3342 0095
Email address
nasrinpourhabibi3497@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of an educational-supportive virtual intervention on treatment adherence among patients with Type 2 diabetes with limited health literacy
Public title
Evaluating of an educational intervention on Treatment adherence among patients with Type2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 30 yrs.
Limited health literacy
Low treatment adherence
Type 2 diagnosis confirmed at least 6 months before
Willingness to participate in the study
Exclusion criteria:
Pregnant women with gestational diabetes
Type 1 diabetes
Comorbidities not related to type 2 diabetes (such as types of cancers and autoimmune system diseases, etc.)
Approved psychological problems
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
264
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using random permuted blocks method by R software R(https://www.r-project.org/). It will make six possible sequences; these are AABB, ABAB, ABBA, BAAB, BABA, BBAA. The different diabetic centers will be alphabetically coded (e.g. A, B, C, D and so on) and a participant will attach to each diabetic center will be given numerical codes (e.g. participants in diabetic center Y were numbered A001, A002, A003 and so on).It is noted that patients with type 2 diabetes has medical records in each diabetes center.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, School of Public Health, Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14155-6446
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.TUMS.SPH.REC.1399.250
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
Health literacy
ICD-10 code
Z41
ICD-10 code description
Encounter for procedures for purposes other than remedying health state
3
Description of health condition studied
Treatment adherence
ICD-10 code
Z71
ICD-10 code description
Persons encountering health services for other counseling and medical advice, not elsewhere classified
Primary outcomes
1
Description
Health literacy
Timepoint
Before and three months after intervention
Method of measurement
Health literacy questionnaire
Secondary outcomes
1
Description
Adherence to treatment
Timepoint
Before and six months after intervention
Method of measurement
Modanloo Questionnaire
2
Description
HbA1c
Timepoint
Before, three and six months after intervention
Method of measurement
Patient medical records (Blood test)
Intervention groups
1
Description
Intervention group: Participants will be invited to complete the questionnaires at the baseline, three and six months after the end of intervention. Both intervention and control groups will be attended the regular diabetes education in the diabetes center. In addition, the intervention group will be received virtual educational program based on Empowerment Model constructs in eight episodes lasting 45–60 minutes in every week for two months. The constructs include perceived threats, participation, evaluation and follow up. These constructs will be considered regarding improvement of adherence to treatment among patients with type 2 diabetes. Moreover, text messages will be sent as a boosting after intervention that serves as a quick reference to the education. The content of educational programs will be included information about treatment adherence based on proper health literacy strategies and diabetes complications about not adherence to treatment. The trainers will be followed an approved lesson plan to provide educational information regarding adherence to treatment. The trainers will be skilled health providers who have at least bachelor degree. The theoretical framework of the study will be based on Empowerment Model to provide an opportunity to improve health literacy to achieve better treatment adherence for participants.
Category
Prevention
2
Description
Control group: This group will be received only the routine diabetes education in centers. There will be no more intervention for control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Erfan Health Diabetes Clinic
Full name of responsible person
Ali Asghar Abbasi
Street address
Jahad Ave.
City
Kerman
Province
Kerman
Postal code
7619738379
Phone
+98 34 3244 5853
Email
info@diabeterfan.com
2
Recruitment center
Name of recruitment center
Bahonar Hospital Diabetes Clinic
Full name of responsible person
Mahdi Ahmadinejad
Street address
Gharani Ave.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
m.ahmadinejad@kmu.ac.ir
3
Recruitment center
Name of recruitment center
Shafa Hospital Diabetes Clinic
Full name of responsible person
Mahmoud Nekouei Moghaddam
Street address
Kowsar Blvd.
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
mahmood.nekoeimoghadam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blvd, Poursinia Street ,vice chancellor for research of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Roya Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 4293 3055
Fax
Email
sadeghir@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3055
Email
sadeghir@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 4293 3055
Fax
Email
sadeghir@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available