The effect of using disease management Smartphone based application on perceived stress and self-efficacy of caregivers of the elderly with Parkinson's disease
Determining the effect of using disease management Smartphone based application on perceived stress and self-efficacy of caregivers of the elderly with Parkinson's disease
Design
This study will be a two-group randomized clinical trial on 60 elderly caregivers with Parkinson's disease in two groups of 30 intervention and control based on "available" sampling and randomly assigned participants to two groups using random sampling method. Block construction will be done. To prevent the publication of content between the two groups, a special code is considered for each person using the application. The intervention phase will last for one month and the results will be analyzed and reported with SPSS software.
Settings and conduct
This study will be performed on elderly caregivers with Parkinson's disease who refer to the Neurology Clinic of Ghaem Hospital, Imam Reza Neurology Clinic and the office of respected specialists of the project. Blinding and hiding the group of people will be done using envelopes and special numbers.
Participants/Inclusion and exclusion criteria
Elderly caregiver:
1. Spend the most time caring for the elderly with Parkinson's.
2. Having a smart phone
3. Age 18 to 60 years
4. Literacy
5. No history of mental disorders
6. Do not use anti-anxiety and sedative drugs
Exclusion criteria:
1. Occurrence of acute debilitating disease during the study
2. Dissatisfaction with continuing the study
Intervention groups
After training the caregivers of the application, intervention groups will be installed on mobile phones.
The control group will use the training items provided in the application in the pamphlet. During the one-month intervention, research units will be contacted at least once a week regarding application usage and potential problems.
Main outcome variables
Perceived stress levels of caregivers; Self-efficacy caregivers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210530051443N1
Registration date:2021-09-15, 1400/06/24
Registration timing:registered_while_recruiting
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
hossein sanaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4346 3273
Email address
sanaeih18@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-05, 1400/04/14
Expected recruitment end date
2021-10-06, 1400/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using disease management Smartphone based application on perceived stress and self-efficacy of caregivers of the elderly with Parkinson's disease
Public title
The effect of using disease management application on elderly caregivers with Parkinson's disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly caregiver: Spend the most time caring for the elderly with Parkinson's
Elderly caregiver: Having a smart phone
Elderly caregiver: 18 to 60 years old
Elderly caregiver: No history of mental disorders
Elderly caregiver: literacy
Elderly caregiver: Do not use anti-anxiety and sedative drugs
Elderly: Age over 70 years
Elderly: The definitive diagnosis of Parkinson's has been confirmed by a neurologist
Elderly: Existence of moderate to high cognitive status according to MSE questionnaire
Elderly: No history of stroke
Elderly: No underlying mental illness
Exclusion criteria:
Caregiver exclusion criteria: Acute debilitating disease during the study
Caregiver exclusion criteria: dissatisfaction with the continuation of the study
Elderly Exclusion Criteria: hospitalization
Elderly Exclusion Criteria: Change of the elderly caregiver
Elderly Exclusion criteria: Acute problems such as heart attacks and strokes, debilitating infections, heavy bleeding, any other disease that reduces the patient's level of consciousness
Elderly Exclusion Criteria: Transfer to a nursing home
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done randomly in the "available" type and the participants will be assigned to two groups randomly using the block randomization method. Blocking is usually done to balance the number of specific samples. One of the studied groups is used in this study, blocks are randomly selected using SPSS software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is one-way blind method in which patients are first randomly assigned to two groups, and the researcher when assigning individuals to two groups will do randomly.
In the data analysis stage, the groups will enter the software as A and B and the analyzer will be unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Bojmehran village, Shafa alley, Mohammad Hassan Sanaei house
City
neyshbour
Province
Razavi Khorasan
Postal code
93441-73427
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.003
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Perceived stress is the body's response to a change that requires adaptation or a physical, mental, or emotional response; stress can be triggered by any stressful factor or stimulus. The caregiver's score is based on Cohen's Perceived Stress Inventory (PSS), which has 14 questions and is used to measure perceived stress in the past month. A high score indicates high stress and a low score indicates low stress.
Timepoint
This variable will be measured first and then one month after the start of the study.
Method of measurement
Perceived Stress Scale
2
Description
Self-efficacy is a degree of a person's sense of mastery over the ability to perform the desired actions. Practical definition: The score obtained by the self-efficacy questionnaire with 35 questions and the higher the score, the higher the self-efficacy indicator is considered. This questionnaire has five dimensions. These include caregiver self-efficacy in gathering information about treatment, symptoms and health care, gaining support, responding to problem behaviors, managing home, personal and medical care, and controlling distressing thoughts about care.
Timepoint
This variable will be measured first and then one month after the start of the study.
Method of measurement
Revised Caregiving Self-Efficacy Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the application is prepared. Application capabilities include teaching various items such as name, mode of action, how to better use drugs, drug interactions, doses, side effects, management and non-drug therapies, proper exercise, disease risk symptoms, proper nutrition and food, medication reminders Reminders to see a doctor, the ability to communicate with the treatment team, etc. are important cases for the next visit to the doctor. Then a meeting will be held with research units to teach how to use the application, which will be held in accordance with the opinions of caregivers in the faculty or clinic. After learning how to use, the application will be installed on their mobile phones. The researcher gives his / her phone to the research units so that if he / she has any questions, he / she can answer them. Also, during the research, the research units will be contacted at least once a week regarding the use of the application and possible problems. In order to prevent the publication of content between the two groups, a special code has been considered for each person using the application, so that the caretaker will not be able to install this application on other devices without prior notice.
Category
Behavior
2
Description
Control group: The trainings are routinely provided based on the contents of the application. The researcher gives his / her phone to the research units so that he / she can answer any questions. Also, during the research, at least once a week, the research units will be contacted regarding the use of educational items and possible problems.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Najmeh Valizadeh Zare
Street address
Imam Reza Research and Treatment Center, Imam Reza (AS) Hospital Square, Ibn Sina St., Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
IRH.CRU@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Najmeh Valizadeh Zare
Street address
Ghaem Hospital, Ahmadabad St., Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Valizadeh Zare
Street address
Danesh va Salamat Town , between Shahid Javan and Al-Shahidi Squares, Shahid Fakoori Boulevard, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3879 5031
Email
presidentoffice@mums.ac.ir
Web page address
Grant name
The Vice Chancellor for Research Department at Mashhad University of Medical Sciences
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
Hossein Sanaei
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Danesh va Salamat Town, between Shahid Javan and Shahid Square, Shahid Fakuri Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 4346 3273
Email
sanaeih18@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Valizadeh Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Danesh va Salamat Town, between Shahid Javan and Shahid Square, Shahid Fakuri Boulevard, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3879 5031
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
Hossein Sanaei
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Danesh va Salamat Town, between Shahid Javan and Shahid Square, Shahid Fakuri Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 4346 3273
Email
sanaeih18@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Caregiver questionnaires can be shared after deleting the names at the end of the study.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only people who work in universities and should be doing research related work.
Under which criteria data/document could be used
Analyzes have no limits. Researchers must make a written commitment that the information will not be published anywhere and that the results of the analysis will be published with the permission of the principal investigator. The researcher must also provide evidence of his or her involvement in ongoing research.
From where data/document is obtainable
In order to receive information, the request must be sent in writing to the email address ValizadehN@mums.ac.ir.
What processes are involved for a request to access data/document
After receiving the request in the mentioned e-mail, MIT.and information will be provided to her after one month.