The aim of this study is to determine the effect of online supportive education program on resilience and family abuse of dementia patients.
Design
A clinical trial with control group, with parallel groups , randomize by the method of quadruple blocks; designed on 74 family members. Blinding will only be done for statisticians.The online randomization service will be used for randomization.
Settings and conduct
The Iranian Alzheimer's Association will be the field of study. The online support educational program will be held for 2 months . Resilience and abuse of family members will be measured by questionnaires before and after the intervention. Blinding will only be done for the statistician.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 18 and 70 years of family members, at least one year of caring for a dementia patient at home, having a smart phone, and access to the Internet and virtual networks are inclusion criteria of this study.
Exclusion criteria: Physical, mental illness and addiction of a family member, use of sedatives and participation in educational and support programs similar to this study in the past
Intervention groups
Intervention group: Participants will receive an online support educational program includes an explanation of dementia, treatment and care for patients , and abuse and neglect of care. This program lasts for 2 months by holding 4 training sessions and then education and questions and answers through virtual networks.
Control group: Participants will only receive routine education of Alzheimer's Association.
Main outcome variables
Resilience of family members, Abuse of a person with dementia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210425051076N1
Registration date:2021-08-22, 1400/05/31
Registration timing:prospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Mojgan Afshari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4243 1887
Email address
moj.afsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Online Educational - Supportive Program on Family’ Resilience and Abuse in People with Dementia
Public title
Online supportive educational program for family member of dementia patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Spouse, child, sister, brother or grandchild of people with dementia
Existence of a patient record in the Alzheimer's Association
Have at least one year of care for a patient with mild to moderate dementia
Caring for an suffering person at home
If two or three people care for a person with dementia at home, one of these family members who spends more time caring for a person with dementia will be included in the study.
Having a smart phone
Access to internet and virtual networks
Exclusion criteria:
Physical and mental illness of a family member
Addiction of a family member based on self-declaration
Taking sedatives by a family member
Recent crisis events or events such as the loss of loved ones and divorce
Caring for another person in the family due to underlying disorder, disability, etc
Participate in supportive and educative programs similar to this study in the past
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
At first sampling will be convenient, it means family members of the patients who has the inclusion criteria will be entered to the study. afterwards family members of the patient will be divided to the control / intervention groups by block randomization method using an online randomization service (http//www.sealedenvelope.com/simple-randomiser/v1/lists). the block size will be 4 and the allocation ratio will be 1:1. Allocation Concealment will be done by sealed envelopes. Block randomization and allocation concealment will be done by a statistician and then will be provided to the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study will be done only for statisticians (data analyzer).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation, Tehran University of
Street address
School of Nursing and Midwifery,Tehran University of Medical Sciences, Nosrat street. Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-04-28, 1400/02/08
Ethics committee reference number
IR.TUMS.FNM.REC.1400.023
Health conditions studied
1
Description of health condition studied
Dementia/ Alzheimer
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Resilience
Timepoint
Before intervention and immediately after intervention
Method of measurement
Walsh Family Resilience Questionnaire
2
Description
Abuse
Timepoint
Before intervention and immediately after intervention
Method of measurement
Caregiver Abuse Screening tool
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group:will receive the education program by holding sessions on the Skyroom / Skype platform (at least three one-and-a-half-hour sessions over 2 months). In these sessions, dementia, human identity and examples of abuse and methods to increase resilience will be taught. In the intervals between the sessions, additional training and support of the participants will be provided through the WhatsApp group. If necessary, voice / video contact will be appoint with the caregivers and the necessary explanations will be given regarding the mentioned questions.
Category
Other
2
Description
Control group: During the study, the control group will not receive any educational support program from the researcher and will only receive the routine education from the Alzheimer's Association. It is noteworthy that the intervention group will also receive these routine education.These routine educations include general tips in caring for these patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Alzheimer's and Dementia Association
Full name of responsible person
Masoumeh Salehi
Street address
Next to the municipality of District 6, the beginning of the exit to Sattari North, Basij square, between phase 1 and 2, Ekbatan town, Tehran
City
Tehran
Province
Tehran
Postal code
1396956144
Phone
+98 21 4463 3555
Fax
+98 21 4465 1122
Email
info@iranalz.ir
Web page address
https://iranalz.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraian
Street address
Research and Technology Management Unit, Room 605, Sixth Floor, Headquarters of Tehran University of Medical Sciences, Corner of Ghods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 8163 3639
Fax
+98 21 8988 1837
Email
resdeputy@tums.ac.ir
Web page address
https://rmo.tums.ac.ir/
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
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
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Afshari
Position
Student of M.s.c
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tums Dormotories.AmirAbad.North Kargar St.Tehran
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 31 4243 1887
Fax
Email
moj.afsh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery،East Nosrat ST،Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Fax
Email
l-sayadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Afshari
Position
Student of M.s.c
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tums Dormotories.AmirAbad.North Kargar St.Tehran
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 31 4243 1887
Fax
Email
moj.afsh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available