The goal of this clinical intervention is to empower clients with family-centered empowerment to improve quality of life andactivity daily living . This study was designed based on a family-centered empowerment model on quality of life and activity daily living of clients with permanent pacemaker. A clinical trial was double blind (Related to study subjects (patients), Committee for the Study of Study Information (Information analysts are in the middle or end stages of the study )that conducted on 60clients that contrive permanent pacemaker who had entered the study, randomly divided into two groups of intervention and control.Interventions during family-oriented sessions A family-centered empowerment model has a step-by-step implementation phase that should be interconnected and integrated. These four main steps, which are based on the family-center empowerment model, are: Includes: 1. Increased perceived threat by increasing knowledge. 2. Promoting self-efficacy by using problem-solving method. 3. Increasing self-esteem through educational participation. Step 4-Evaluation. Prior to the start of the steps, a questionnaire for quality of life and activitiy daily living is carried out by two groups of control and after 8weeks educated, we filling the questionaries of activity daily living and quality of life from two group for analyze.
finally I get control group education in one sesstion and get them pamphelats and books.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103137143N1
Registration date:2017-11-19, 1396/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
manejeh toraby
Name of organization / entity
Hospital
Country
Iran (Islamic Republic of)
Phone
+98 913 287 0676
Email address
st-toraby.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of family center empowerment modle on activity daily living and quaility of life in clients chamran heart hospital isfahan
Public title
the effect of family-center empowerment modle on activity daily living and quiality of life in clients with per manent pace maker
Purpose
Supportive
Inclusion/Exclusion criteria
Entry criterion:1.the clients have permanent pace maker.2.the clients agree to participate in. 3.they didn,t have any sychology problem.4.the client have 18until80 years old.5.the clients could have comunication.6.the clients didn,t have auditory problem.7.one of the family person agree to particicipate to intervention.8.they have minimum ability of reading and writing. .9the nearst family that care from client have nesessory khnowledge about his or her client,s illnessand could make disition.
outgoing ceriterion:
the clients dont like percipitate in intervention.2if the clientswii die.3.the client have another problemfor example get sycho sochial problems that dont abble to continue this case.4.any problem that influence on quality of life and activity daily living,for example dieing nearst family or getting another problems with his or her heathy.
Age
From 17 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
after I meet the client that who has entry requirements i get consent letter and I get client agroup cards that provide them enough to clients and mix them . the client randomly pick up one of the gruop cards .if the card is A the client is in the intervention group and if the client is the Bgroup she or he is in the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
MEDICAL SURGICAL SCIENTS
Street address
CHAHAR MAHAL AND BAKHTIARI
City
SHAHREKORD
Postal code
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.SKUMS.REC1396.172
2
Ethics committee
Name of ethics committee
IR.SKUMS.REC.1396.172
Street address
SHAHREKORD MEDICAL SCIENCE
City
CHAHARMAHAL AND BAKHTIARI
Postal code
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.SKUMS.REC1396.172
Health conditions studied
1
Description of health condition studied
the clints with permanent pace maker
ICD-10 code
152
ICD-10 code description
Other heart disorders in diseases classified elsewhere
Primary outcomes
1
Description
family center impowerment modle
Timepoint
15daiy until one month
Method of measurement
QUISTIONARY
Secondary outcomes
1
Description
activity daily living and quality of life
Timepoint
8weeks
Method of measurement
QUISTIONARY
Intervention groups
1
Description
the intervention will be in the interventional group.at first we tell clients how pace maker works and what should or shouldnt they do. then in some session we want the clients tell what they know about pacemaker to one of person in their family that in client,s treatment is active. then we evaluate them with questionarys after 8weeks.but control groupwill get ruling eduction in hospitaland after 8weekswe we will evalute they, then we,ll compare two group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
chamran heart hospital in esfahan
Full name of responsible person
mrs doctor shirani
Street address
esfahan
City
esfahan
2
Recruitment center
Name of recruitment center
chamran heart hospital in esfahan
Full name of responsible person
doctor rezvan normand
Street address
esfahan
City
esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shahrekord University of Medical Sciences
Full name of responsible person
doctor solati
Street address
shahrekord
City
shahrekord
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, shahrekord 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
shah rekord univercity
Full name of responsible person
manejeh toraby kharaji
Position
master of medical surgical nursing student
Other areas of specialty/work
Street address
shahrekord medical science
City
shahrekord
Postal code
Phone
+98 38 3333 0065
Fax
Email
manejeh.toraby@gmil.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
medical surgical univercity shahrekord
Full name of responsible person
doctor fatemeh ali akbari
Position
nursing doctor
Other areas of specialty/work
Street address
shahrekord
City
shahrekord
Postal code
Phone
+98 38 3333 0065
Fax
Email
aliakbarifa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shahrekord
Full name of responsible person
doctor fereshteh ain
Position
nursing doctor
Other areas of specialty/work
Street address
medical science univercity
City
shahrekord
Postal code
Phone
+98 38 3333 0065
Fax
Email
fereshtehaein@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)