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The effect of self-care education based on the BASNEF model on treatment adherence and life expectancy of elderly people with hypertension

Protocol summary

Study aim
Investigating the effect of self-care education based on the BASNEF model on treatment adherence and life expectancy of elderly people with hypertension
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 96 patients. Randomization computer software will be used for randomization in this study.
Settings and conduct
Eligible elderly people who visit Nik-e-Iqbal clinics and Health Center No. 1 in Jahrom during the study period will be included in the study after obtaining informed consent. Participants will be randomly assigned to two intervention and control groups using random selection computer software. This study will be conducted without blinding, but the data analyst will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 60 years, ability to read and write in Persian, blood pressure grade 1 and 2, and willingness to participate in the study. Exclusion criteria: Physical disability, diseases affecting hypertension such as rheumatoid arthritis, mental disorders, and addiction to drugs or psychotropic substances.
Intervention groups
Intervention group: Participants in this group will participate in a training program based on the BASNEF model. The program will consist of four face-to-face training sessions, one session per week for two hours, over four weeks. The training will include awareness of hypertension, modification of beliefs and attitudes, training in self-care skills (nutrition, physical activity, medication use, stress management), and strengthening life expectancy. Control group: Participants in this group will receive only routine care (routine medical follow-ups, prescription medications, and general advice) from health centers without any special training.
Main outcome variables
Treatment adherence, life expectancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250521065829N1
Registration date: 2025-07-27, 1404/05/05
Registration timing: prospective

Last update: 2025-07-27, 1404/05/05
Update count: 0
Registration date
2025-07-27, 1404/05/05
Registrant information
Name
Sahar Erfanmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5444 7978
Email address
erfanmanesh.sahar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-01, 1404/06/10
Expected recruitment end date
2025-12-01, 1404/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education based on the BASNEF model on treatment adherence and life expectancy of elderly people with hypertension
Public title
The effect of self-care education based on the BASNEF model on treatment adherence and life expectancy of elderly people with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in research Diagnosis of hypertension by a doctor in patients with elevated blood pressure, stage one or two Literacy Age over 60 years
Exclusion criteria:
Physical disability Having diseases that affect high blood pressure, such as Rheumatoid arthritis and kidney disease Having mental disorders Addiction to drugs or other psychoactive substances
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, two health centers with similar demographic and service characteristics, including Health Center No. 1 in Jahrom and Nik Eghbal Health Center, will be selected. Then, using a lottery method, one center will be assigned as the intervention group and the other as the control group. After determining the groups, a list of elderly patients with hypertension covered by each center will be prepared, and each individual will be assigned an identification code. Participant selection in each center will be carried out using a simple random sampling method and random number generator software to ensure equal chances for all individuals to enter the study. Finally, 48 participants from the designated intervention center and 48 participants from the control center will be randomly selected.
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
Research Ethics Committees of Jahrom University of Medical Sciences
Street address
Pardis Site, Jahrom University of Medical Sciences, Ostad Motahari Street, Jahrom, Fars Province, Iran
City
Jahrom
Province
Fars
Postal code
74148-46199
Approval date
2025-04-15, 1404/01/26
Ethics committee reference number
IR.JUMS.REC.1404.007

Health conditions studied

1

Description of health condition studied
Blood pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis

Primary outcomes

1

Description
Treatment adherence
Timepoint
Before and two months after the intervention
Method of measurement
Medanlou questionnaire

2

Description
Life expectancy
Timepoint
Before and two months after the intervention
Method of measurement
Snyder Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Participants in this group received a structured educational program based on the BASNEF model. The intervention consisted of four weekly face-to-face sessions, each lasting two hours, conducted over a four-week period. The sessions included education on hypertension and its complications, correction of misconceptions and negative attitudes, training in self-care skills (such as proper nutrition, physical activity, medication adherence, and stress management), and enhancement of hope and motivation. The educational content was delivered through group discussions, PowerPoint presentations, pamphlets, and booklets. After the sessions, two follow-up visits were conducted to reinforce the training and answer participants’ questions.
Category
Lifestyle

2

Description
Control group: Participants in this group received no special training and were only provided with routine care at health centers. Routine care included routine medical follow-ups, prescription medications, and general health advice.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Nik Iqbal Clinic, Jahrom City
Full name of responsible person
Sahar Erfanmanesh
Street address
Imam Reza Street, Adib Street, Farhangshahr, Jahrom
City
Jahrom
Province
Fars
Postal code
7413653335
Phone
+98 71 5447 5608
Email
erfanmanesh.sahar@gmail.com

2

Recruitment center
Name of recruitment center
Clinic No. 1 in Jahrom City
Full name of responsible person
Sahar Erfanmanesh
Street address
Clinic Number One, Molavi Street, Motahari Boulevard, Koshkak District, Jahrom, Fars Province
City
Jahrom
Province
Fars
Postal code
7413653335
Phone
+98 71 5447 5608
Email
erfanmanesh.sahar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Amir Abdoli
Street address
Vice-Chancellor for Research, Jahrom University of Medical Sciences, Motahari Blvd, Jahrom, Fars Province
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 1501
Email
research@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Sahar Erfanmanesh
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis Campus, Jahrom University of Medical Sciences, After Nursing School, Ostad Motahari Street, Jahrom, Fars Province, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5447 5608
Email
erfanmanesh.sahar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Sahar Erfanmanesh
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis Campus, Jahrom University of Medical Sciences, After Nursing School, Ostad Motahari Street, Jahrom, Fars Province, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5447 5608
Email
erfanmanesh.sahar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Sahar Erfanmanesh
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis Campus, Jahrom University of Medical Sciences, After Nursing School, Ostad Motahari Street, Jahrom, Fars Province, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5447 5608
Email
erfanmanesh.sahar@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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