Protocol summary

Study aim
To determine the effect of the Ask Me 3 educational program on treatment adherence and blood pressure control in adults with hypertension
Design
A randomized parallel clinical trial will be conducted on 94 adults with hypertension. Participants will be randomly allocated (1:1) to the intervention (Ask Me 3 educational program) or control (routine care) group using Random Allocation Software.
Settings and conduct
The study will be conducted in comprehensive health centers in Shahroud. Eligible participants will be recruited from three socioeconomic strata. The intervention group will receive the Ask Me 3 educational program, while the control group will receive routine care.
Participants/Inclusion and exclusion criteria
Entry criteria: 1-Age at least 40 years and older 2-Diagnosis of primary hypertension (systolic 130–139 mmHg and diastolic 80–89 mmHg) 3-Use of at least one antihypertensive medication within the last three months 4-Possession of hearing, speaking, and communication abilities 5-At least three months have passed since diagnosis 6-A minimum score of 10 on the Lawton Instrumental Activities of Daily Living (IADL) scale . 7-A minimum score of 7 on the Abbreviated Mental Test (AMT) 8-Normal result on the Mini-Cog test Exclusion criteria: 1-Diagnosis of acute cardiac, renal, hepatic, or respiratory diseases, malignancies, stroke, or substance addiction. 2-Diagnosis of depression and anxiety documented in the medical record. 3-Participation in similar educational sessions.
Intervention groups
Intervention group: Participants will receive the Ask Me 3 educational program in three face-to-face sessions, along with an educational booklet and weekly telephone follow-up for 12 weeks. Control group: Participants will receive routine care and education provided by the comprehensive health centers.
Main outcome variables
Treatment adherence Blood pressure control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260613069762N1
Registration date: 2026-09-07, 1405/06/16
Registration timing: registered_while_recruiting

Last update: 2026-09-07, 1405/06/16
Update count: 0
Registration date
2026-09-07, 1405/06/16
Registrant information
Name
ruhollah Hadinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4204 8503
Email address
rhadinezhad555@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-01, 1405/06/10
Expected recruitment end date
2026-12-01, 1405/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the “Ask Me 3” Educational Program on Treatment Adherence and Blood Pressure Management in Adults with Hypertension: A Randomized Parallel Clinical Trial
Public title
The Effect of the Ask Me 3 Program on Treatment Adherence and Blood Pressure Control in Adults with Hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age at least 40 years and older Diagnosis of primary hypertension (systolic 130–139 mmHg and diastolic 80–89 mmHg) Use of at least one antihypertensive medication within the last three months Possession of hearing, speaking, and communication abilities At least three months have passed since diagnosis A minimum score of 10 on the Lawton Instrumental Activities of Daily Living (IADL) scale A minimum score of 7 on the Abbreviated Mental Test (AMT) Normal result on the Mini-Cog test
Exclusion criteria:
Diagnosis of acute cardiac, renal, hepatic, or respiratory diseases, malignancies, stroke, or substance addiction Diagnosis of depression and anxiety documented in the medical record Participation in similar educational sessions
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent, a 1:1 random allocation sequence will be generated using Random Allocation Software. The allocation sequence will be prepared by an independent person and kept in sequentially numbered, sealed opaque envelopes. Participants will be assigned to the intervention or control group according to the allocation sequence after enrollment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The educational intervention in this study is based on the Ask Me 3 program and consists of three in-person training sessions, along with telephone follow-ups and the provision of an educational booklet. Furthermore, the socio-economic strata of Shahroud city will be taken into account when selecting the participants.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Shahroud University of Medical Sciences
Street address
7 Tir Square, Next to Shahroud Municipality, Shahroud, Semnan Province, Iran
City
SHAHROUD
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Approval date
2026-06-09, 1405/03/19
Ethics committee reference number
IR.SHMU.REC.1405.062

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
1-Treatment adherence
Timepoint
"At the beginning of the intervention (before the start of the intervention), one week after the end of the intervention, and three months after the end of the intervention."
Method of measurement
1. Modanlou Medication Adherence Questionnaire

Secondary outcomes

1

Description
1-Systolic and Diastolic blood pressure
Timepoint
"At the beginning of the intervention (before the start of the intervention), one week after the end of the intervention, and three months after the end of the intervention."
Method of measurement
Electronic blood pressure monitor

Intervention groups

1

Description
The intervention group will receive the Ask Me 3 educational program in three 45-minute face-to-face sessions over three consecutive days. Each session will focus on one of the three Ask Me 3 questions: “What is my main problem?”, “What do I need to do?”, and “Why is it important for me to do this?”. The content will cover hypertension, medication adherence, healthy diet and salt reduction, physical activity, blood pressure monitoring, and self-care. The sessions will be delivered by the researcher using an educational booklet and poster, followed by weekly telephone follow-up for 12 weeks to reinforce the educational content.
Category
Behavior

2

Description
Control group: Receiving routine education provided by health centers
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
The Health Centers affiliated with shahroud University of Medical Sciences
Full name of responsible person
Ruhollah hadinezhad
Street address
7 Tir Square, Next to Shahroud Municipality, Shahroud, Semnan Province, Iran
City
Shahruod
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Web page address
https://www.shmu.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein ebrahimi
Street address
7 Tir Square, Next to Shahroud Municipality, Shahroud, Semnan Province, Iran
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 6714
Fax
+98 23 3239 4852
Email
vcr@shmu.ac.ir
Web page address
https://shmu.ac.ir/research/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Ruhollah hadinezhad
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13 , Rezvan alley, Yas 60, Kargar street
City
Qaemshahr
Province
Mazandaran
Postal code
4764635938
Phone
+98 11 4204 8503
Email
rhadinezhad555@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ruhollah hadinezhad
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 13 , Rezvan alley, Yas 60, Kargar Street
City
Qaemshahr
Province
Mazandaran
Postal code
4764635938
Phone
+98 11 4204 8503
Email
Rhadinezhad555@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ruhollah hadinezhad
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 13, Rezvan alley, Yas 60, Kargar street
City
Qaemshahr
Province
Mazandaran
Postal code
4764635938
Phone
+98 11 4204 8503
Email
rhadinezhad555@gmail.com

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
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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