Protocol summary

Summary
The present study aims to investigate the effect of home care family centered program on health condition of hemiplegic patients with stroke. It is a not blinded study in second phase. Samples included patients with stroke attending Farabi hospital, Kermanshah. 30 hemiplegic in patients attending neurology department were selected according to their admission in odd or even days and were randomly divided into control and experiment groups. Both groups were asked to fill out health condition questionnaire before starting the intervention. The intervention consisted of training care program to the caregiver during four consecutive days and each session took 50 to 60 minutes. In intervention group, After ensuring the empowerment of carers, they were asked to take care of the patients at their homes for four weeks and control group will only receive routine training on discharge. Finally, both groups were asked to complete the health condition questionnaire again and results were compared. Inclusion criteria: patient’s consent; recognizing hemiplegic stroke in patients by doctors; no mental disorders, no drug abuse; full consciousness and being able to answer the questions. Exclusion criteria; cutting the cooperation at any moment Prematurely patient discharge or death.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070214333N38
Registration date: 2015-08-28, 1394/06/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-28, 1394/06/06
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the efficacy and inefficacy of home care family centered program on health of hemiplegic patients with stroke
Public title
The effect of home care بamily centered program on the health of hemiplegic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient’s consent; recognizing hemiplegic stroke in patients by doctors; no mental disorders, no drug abuse; full consciousness and being able to answer the questions. Exclusion criteria; cutting the cooperation at any moment Prematurely patient discharge or death.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized by sealed envelope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
Kums.Rec.1394.34

Health conditions studied

1

Description of health condition studied
Complications of cerebrovascular disease
ICD-10 code
I 69
ICD-10 code description
Sequelae of cerebrovascular disease

Primary outcomes

1

Description
Health condition
Timepoint
At the beginning of the study and four weeks after conducting the study
Method of measurement
Based on health status questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In experiment group, The intervention included a care training program to the caring person held in 4 consecutive days; each session took 50 to 60 minutes. Making sure that trained people could properly take care of the patients, they were asked to serve the patients at their homes for four weeks.
Category
Behavior

2

Description
Control group, simply received the routine trainings while discharge.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Hadis Faramarzi
Street address
Farabi Hospital, Dolatabad Boulvard,Eisar Square
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Arsalan Naderipour
Position
Ms.c of Nursing Training
Other areas of specialty/work
Street address
School of Paramedical Sciences, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9697
Fax
Email
naderipoura@yahoo.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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