Protocol summary

Summary
The purpose of this research is recognizing Influence of family centered care program on adherence of therapeutic regime on stroke patient.Inclusion criteria included patients with ischemic stroke were 4 and 5 degrees Rankine scale and primary caregivers in the patient's family should have more than 4 days per week of patient care.exclusion criteria included Change in primary care patients during the study period and placing the patient in the end stage of the disease.Research on patients with stroke and their primary care experience in both groups (30 patients) and comparison (n = 30) were performed.Comparison group, the received the rotin hospital program and experimental group received family-centered care programs Including needs assessment, training , telephone follow up and refer.Study period for each sample was 2 months.variable for assessment include Demographic data and adherence of therapeutic regimen in three areas of the rehabilitation, Food and Drug regimen.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202128978N1
Registration date: 2012-03-18, 1390/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-18, 1390/12/28
Registrant information
Name
Nahid Dehghan Nayeri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4313
Email address
dehghann@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-04-17, 1390/01/28
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-based care program on adherence of treatment regimen in patients with stroke
Public title
The effect of using family-based care program on adherence to treatment regimen in stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patient with first stroke; Rankin Scale score of 4-5,Patients discharged to home after hospitalization; Patients stay at least 5 days in hospital;there is primary carer of patients in the hospital for implementing of family centered carethe program; Primry care patients at least 4 days a week to take care of the patient,Home carer patients are literatur;we can contact with primary carer of patients. Exclusion criteria: changes in individual patient care; Putting the patient at the end stage of disease according to the doctor.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
School of nursing and midwifery , Tohid Sq. Tehran
City
Tehran
Postal code
1419733171
Approval date
2011-04-17, 1390/01/28
Ethics committee reference number
13169

Health conditions studied

1

Description of health condition studied
Brain stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
adherence to treatment regimen
Timepoint
2 months after discharge
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Family-centered care plan has four parts : Assessment, family education based onpatient care need , Telephone follow-up care after discharge,Coordination and referrals between family and health care providers in related to caring of patient. 48 hours after patient admission, the questionnaire of demographic data for primary caregivers and patient filled by the researcher. in needs assessment stage, check list in three areas of assessment, rehabilitation, diet and medication regimen was completed.Educational content according to the need assessment, was prepared in three parts. family education developed and implemented based on andragogy theory. family education were conducted on 3 consecutive days in the hospital.Reassessment was done in training.Illustrated educational booklet was given to the patient's primary caregiver.In the thelephon follow-up after discharge, Each week, call the family carer for educationa need and resolve care problems.in the referral stage, medical teams of each patient was identified and communication way with the treatment team, was foun and if necessary, appropriate reference was introduced to family for solve the care problem.After two months after the intervention, the questioniare of adherence of therapeutic regimen was assessed via telephone.
Category
Other

2

Description
Comparing groups within two months of research applications received routine hospital program. After two months , the questioniare of adherence of therapeutic regimen was filled via telephone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shriati Hospital
Full name of responsible person
Sepideh mohamadi
Street address
Shriati Hospital, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Imam Khomaini Hospital
Full name of responsible person
Mozhde ghabaee
Street address
Imam Khomaini Hospital,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Mrs arimi - expert of proposal
Street address
The sixth floor, structure of TUMS, the Qods St. Keshavarz Boulevard, Tehran , Iran
City
Tehran
Grant name
پايان نامه
Grant code / Reference number
13169
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
Tehran Univesity of Medical Sciences
Full name of responsible person
Nahid Dehghan Nayeri
Position
PhD, Associate professor
Other areas of specialty/work
Street address
School of nursing and midwifery , Tohid sq. Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4313
Fax
Email
nahid.nayeri@gmail.comdehghann@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nahid Dehghan Nayeri
Position
PhD
Other areas of specialty/work
Street address
School of Nursing and Mdwifery, Tohid Sq, tehran
City
Tehran
Postal code
Phone
+98 21 6105 4313
Fax
Email
dehghann@tums.ac.irnahid.ayeri@gmail.com
Web page address

Person responsible for updating data

Contact

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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