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IRCT20210530051443N1 IRCT 2021-09-15 Mashhad University of Medical Sciences The effect of using disease management application on elderly caregivers with Parkinson's disease The effect of using disease management Smartphone based application on perceived stress and self-efficacy of caregivers of the elderly with Parkinson's disease 2021-07-05 anticipated 60 Complete https://irct.ir/trial/56635 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 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. N/A Parkinson's disease. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Caregiver questionnaires can be shared after deleting the names at the end of the study. When: Access period starts 6 months after the results are published To whom: Only people who work in universities and should be doing research related work. Conditions: 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. Where to obtain: In order to receive information, the request must be sent in writing to the email address ValizadehN@mums.ac.ir. How to obtain: After receiving the request in the mentioned e-mail, MIT.and information will be provided to her after one month. Comments:
public Hossein Sanaei
Danesh va Salamat Town, between Shahid Javan and Shahid Square, Shahid Fakuri Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 4346 3273 sanaeih18@yahoo.com Mashhad University of Medical Sciences scientific Najmeh Valizadeh Zare
Danesh va Salamat Town, between Shahid Javan and Shahid Square, Shahid Fakuri Boulevard, Mashhad
mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3879 5031 ValizadehN@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 60 years Both 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 G20 Parkinson's disease Behavior Behavior 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. 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. 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. 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. Mashhad University of Medical Sciences Approved 2021-03-01 Ethics Committee of the School of Nursing and Midwifery - Mashhad University of Medical Sciences Bojmehran village, Shafa alley, Mohammad Hassan Sanaei house neyshbour Razavi Khorasan Iran (Islamic Republic of)