1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Effect of cognitive-behavioral management education on Alzheimer's family caregiver's burden
Protocol summary
Summary
Title: Effect of cognitive-behavioral management education on Alzheimer's family caregiver's burden.
Objectives: Reviewing the effect of cognitive-behavioral management education on Alzheimer's family caregiver's burden. Design: This study is a non-randomized study with pre-post design with control group. The population that the study is based on are family caregivers of people with Alzheimer's. Major inclusion criteria for the study are: Being relatives of the patient; Being the main caregiver; The patient should be in second stage of Alzheimer's disease(stage of cognitive-behavioral disorders), Major Exclusion criteria for this study are:
Death of the patient with Alzheimer's; The participant not interested in continuing the practice. Setting and
conduct: The number of samples considered in this study is 70, 35 in the intervention group and 35 patients in the control group. The cognitive-behavioral management education will be given to the intervention group. Before starting the intervention, burden of the participants in both groups is measured by the questionnaire. These educations are provided in 4 sessions during 2 weeks.
Sampling for this study will be started at 01.09.2014. By comparing the results of this study at the end, we can measure the effect of cognitive-behavioral management education on burden of Alzheimer's family caregivers and if it was effective on burden of caregivers, the education can be used for reducing caregiver's burden.
General information
Acronym -
IRCT registration information
IRCT registration number: IRCT2014081818847N1 Registration date: 2015-01-09, 1393/10/19 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2015-01-09, 1393/10/19 Registrant information
Name
Ladan Bagherbeik Tabrizi Name of organization / entity
Tehran University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 21 8877 0599 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date 2014-09-10, 1393/06/19
Expected recruitment end date 2014-12-31, 1393/10/10 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Effect of cognitive-behavioral management education on Alzheimer's family caregiver's burden
Public title
Clinical traial of the effect of education on Alzheimer's caregiver's burden
Purpose
2 Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having informed consent; Being relatives of the patient; Being the main caregiver; Caring of the patient at least for 6 months and a maximum period of 1 year; Having the capacity to respond to the questionnaire; The patient should be in second stage of Alzheimer's disease (stage of cognitive behavioral disorders); The caregiver not being affected by any mental illnesses and do not use any drugs. Exclusion criteria: Death of the patient with Alzheimer; The participant not interested in continuing the practice;
Entrust the care of patient with Alzheimer to other health facilities or other people.
Age
No age limit Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 70
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences (office building), Qods street, Keshavarz Blvd, Tehran, Iran City
Tehran Postal code Approval date
2013-09-15, 1392/06/24
Ethics committee reference number 3641
Health conditions studied
1
Description of health condition studied Alzheimer's
ICD-10 code G30.9
ICD-10 code description Alzheimer disease, unspecified
Primary outcomes
1
Description Burden Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement Questionnaire
Secondary outcomes empty
Intervention groups
1
Description
Intervention group: At first caregiver's burden will be measured by the questionnaire then the cognitive- behavioral management training will be provided for this group. This education will be in 4 sessions in period of 2 weeks. The package that will be trained to the
participants in this group has headings such as hallucination and illusion management, sun set syndrome, being lost out of the house, restlessness management and repeating the words.
Category Behavior
2
Description
Control group: In control group, there will be no
interventions. The burden questionnaire will be answered by the participants in this group and 6 weeks after training finished in intervention group, burden will be measured by the questionnaire again.
Category N/A
Recruitment centers
1
Recruitment center
Name of recruitment center Iran Alzheimer's Association Full name of responsible person
Leila Hafarian, study and research coadjutor
3 Street address
Iran Alzheimer's Association, Basij squer, Ekbatan mini town, Tehran, Iran
City Tehran
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizadeh, Tehran Nursing and Midwifery School research assistant director
Street address
Tehran Nursing and Midwifery School, Nosrat street, Tohid square, Tehran,Iran
City Tehran 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, 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 University of Medical Sciences Full name of responsible person
Ladan Bagherbeik Tabrizi Position
Master student of geriatric nursing Other areas of specialty/work Street address
Tehran University of Medical Sciences, Qods street, Keshavarz Blvd, Teran, Iran
City Tehran Postal code Phone
+90 218 877 05 99 Fax
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Ladan Bagherbeik Tabrizi Position
Master student of geriatric nursing Other areas of specialty/work Street address
Tehran University of Medical Sciences, Qods street, Keshavarz Blvd, Tehran, Iran
City Tehran Postal code Phone
+98 21 8877 0599 Fax
[email protected] Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences, Nursing and Midwifery school
Full name of responsible person Ladan Bagherbeik Tabrizi Position
Master student of geriatric nursing Other areas of specialty/work Street address
Tehran University of Medical Sciences, Qods street, Keshavarz Blvd, Tehran, Iran
City Tehran Postal code Phone
+98 21 8877 0599 Fax
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
4 Clinical Study Report
empty Analytic Code
empty Data Dictionary
empty
