Protocol summary

Summary
This study was conducted with the aim to investigate the effect of Tele-nursing-based empowerment program on self-efficacy in the elderly with hypertension. Study inclusion criteria are being aged between 65 and 80 years; having no dementia or cognitive impairment; no hearing or speech problems or mental disorders; not suffering from hypothyroidism or diabetes and exclusion criteria are death; hospitalization in the course of study. The study population consists of 84 elderly with hypertension attending Saiad Shirazi Hospital in Golestan province, Iran. Educational intervention contains speech, group discussion, and questions and answers (educational workshop) for both groups. Educational content of the booklet is validated by professors of Nursing and Midwifery School-Tehran University of Medical Sciences. Telephone intervention is carried out in the trial group for 12 weeks. Participants will be verbally encouraged and advised to comply with healthy behaviors through telephone calls and all the conversation will be recorded on a form. Control group does not undergo any Tele-nursing intervention. After 12 weeks of empowerment intervention, self-efficacy questionnaire is once again completed by both groups (post-test).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031516997N1
Registration date: 2014-05-17, 1393/02/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Yosof Behzad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2875
Email address
y-behzad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-06, 1393/02/16
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tele-nursing-based empowerment program on self-efficacy in the elderly with hypertension
Public title
The effect of an education program with telephone follow-up on the health behaviors of elderly patients with hypertension
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: aged between 65 and 80 years; living in Golestan province; access to telephone at home; having no dementia or cognitive impairments; no hearing or speech problems or mental disorders; no hypothyroidism or diabetes Exclusion criteria: death; unwillingness to continue participation; discontinued telephone contact for 2 weeks in the first month of intervention; or 3 weeks in the 2nd and 3rd.
Age
From 65 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
88989664
Approval date
2014-04-16, 1393/01/27
Ethics committee reference number
106/130/د/93

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
110
ICD-10 code description
High blood pressure

Primary outcomes

1

Description
Self Efficacy
Timepoint
Before and after the intervention will be measured
Method of measurement
Efficacy Questionnaire in patients with hypertension with appropriate validation

Secondary outcomes

empty

Intervention groups

1

Description
To implement empowerment program, an educational session will be provided in the form of speeches, group discussion and questions and answers (educational workshop) for both trial and control groups. The workshop will be a 2-hour session in a day for patients with hypertension. Prior to selection of subjects, patients will complete pretest questionnaire in presence of the researcher (before intervention). Then, educational subjects about nature of hypertension, complications and control methods, principles of medication therapy, medication side-effects, reinforcement of appropriate behavior in disease control and stress management, DASH diet, and appropriate exercise for hypertension are provided. It should be noted that educational subjects are presented over 50 minutes with 15 minutes rest in the middle, and educational booklets containing the subjects discussed will be issued to participants by the end of the session. Afterwards, telephone intervention will be conducted for the trial group over 12 weeks. Twice weekly telephone contacts will be made to trial group members in the first month, and once a week in the 2nd and 3rd months. Timing of calls is agreed between the researcher and the elderly, any time between 8 am and 2 pm, and each telephone conversation will last 15 minutes on average. Study subjects can call the researcher between 8 am and 2 pm if necessary. In the first part, telephone conversations will focus on verbal encouragement for health behaviors in the elderly regarding educational workshop subjects, and the second part will be based on particular requirements of each elderly in relation to hypertension self-care, and while health behaviors are encouraged, necessary advice is also provided. Content of every conversation is recorded on a form.
Category
Other

2

Description
In the course of study, control group does not receive any kind of tele-nursing intervention (except receiving empowerment programs in educational workshops and routine medicinal treatment).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayad Shirazi Hospital
Full name of responsible person
Yosof Behzad
Street address
Sayad Shirazi Hospital, Golestan, Iran
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Unesian
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
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
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
School of Nursing and Midwifery, Tehran
Full name of responsible person
Yosof Behzad
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Tehran School of Nursing and Midwifery, Touhid Square, Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
behzadyosof@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Iran
Full name of responsible person
Dr. Faride Bastani
Position
Associate
Other areas of specialty/work
Street address
Rashid Yasemi St., Vanak Sq., Valiasr St., Tehran, Iran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
faridehbastani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran
Full name of responsible person
Yosof Behzad
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Touhid Square,Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
behzadyosof@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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