Determining the Impact of Family-Based Empowerment Model on Caregivers Carers in Parkinson's Elderly
Design
This training has two groups of control and intervention and the selection of groups based on simple randomization The sample size of 30 patients for the intervention group and 30 patients for the control group is estimated. In this study, the parallel study design is a pragmatic type of practice.
Settings and conduct
This study will be carried out on the main carers of Parkinson's andParkinson's elderly patients referred to the special clinic of Ghaem Hospital in Mashhad. The research units will be divided into two groups of intervention and control before intervention. The care burden questionnaire was completed in both groups, then in the intervention group, a family-centered empowerment model consisting of 4 sessions of empowerment education (weekly 2sessions of 45 minutes) will be held. This four-step pattern of perceived threat, problem-solving, participation Training and evaluation. Family-bempowerment program in K School will be held As·hay
Participants/Inclusion and exclusion criteria
Major caregivers to study: Family members and primary caregivers of an elderly patient with Parkinson's disease. He has been taking care of the patient for at least 6 months. The main caregiver will have the desire to participate in the study. The main educator should have read and write literacy.
Intervention groups
In the intervention group, a family-centered empowerment model consisting of 4 sessions of empowerment training (weekly 2 45-minute sessions) will be held. This is a four-step pattern of perceived threat, problem-solving, learning participation, and evaluation.
Main outcome variables
Caregivers Career Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041342N1
Registration date:2018-11-05, 1397/08/14
Registration timing:prospective
Last update:2018-11-05, 1397/08/14
Update count:0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Somayeh Bagheri aghoei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5229 9245
Email address
bagherias951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of family-centered empowerment model implementation on family caregivers burden Parkinson's Elderly
Public title
the effect of family-centered empowerment model implementation on family caregivers burden Parkinson's Elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Seniority Entry Criteria: Age over 60
A definitive diagnosis of Parkinson's has been confirmed by a brain specialist.
Except for Parkinson's disease, there is no other significant disease (cancer, dementia, speech impairment, deafness, debilitating heart disease, respiratory, renal disease)
Elderly tend to participate in the study
Major caregivers entry rates: Family members and primary caregivers of an elderly patient with Parkinson's disease.
Take care of the patient for at least 6 months.
The main investigator will have the desire to participate in the study.
The main educator should have read and write literacy.
Exclusion criteria:
Exit criteria. Watch out for study: Refrain from continuing to participate in the study and collaborating with the researcher
Disease disease Other diseases
The emergence of conditions that the patient's caregiver can not use from the provided training
Caring for someone else to take care of Parkinson's disease to another person or to care centers
The failure of the main caregiver in more than one session of the classroom
Expiry criteria for the study: Unwillingness to participate in the study
In the event of a specific disease during the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
The patient's primary caregiver along with the patient
Randomization (investigator's opinion)
Randomized
Randomization description
Simply randomize random numbers by using www.randomization.com
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Ibn Sinah Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
ir.mums.nurse.rec.1397.046
Health conditions studied
1
Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Carer Care Times
Timepoint
At the beginning of the study (before the intervention) at the end of the intervention and one and two months after the intervention
Method of measurement
Zarit's Care Bar Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A family-centered empowerment model consisting of 4 sessions of empowerment education (weekly 2 45-minute sessions). This is a four-step pattern of perceived threat, problem-solving, training participation and evaluation.
Category
Rehabilitation
2
Description
Control group: In the control group, no intervention will be required, but ethically, all training issues of empowerment sessions will be replicated in the form of pamphlet and instruction book, and will be available to the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurological Clinic Ghaem Hospital in Mashhad
Full name of responsible person
Somayeh Bagheri Aghouie
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
bagherias951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vpresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Najmeh Valizadeh Zare
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
valizadehn@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Najmeh Valizadeh Zare
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
valizadehn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Najmeh Valizadeh Zare
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
valizadehn@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD