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IRCT20191027045253N1 IRCT 2020-05-01 Kerman University of Medical Sciences Effectiveness of occupational therapy in dementia patients and their caregivers Evaluation of the effectiveness of occupational therapy technology added to drug therapy compared to drug therapy alone among elderly people with dementia and their caregivers 2018-09-22 anticipated 120 Complete https://irct.ir/trial/43327 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients were randomly assigned to the intervention (12 sessions of home therapy over 6 weeks) and control group (routine care without any occupational therapy), using the randomized block design (block of size four), Blinding description: Participants were divided into two groups: Group I and II: Elderly with Dementia and Control and Group III and IV: Informal caregivers of patients with Dementia and Control. Group I and II: Dementia Patients: Due to the intervention at home and pre and post tests at home, subjects were blinded to the intervention or control group. Group 3 and 4: Unofficial caregivers of dementia: Although pre and post tests were performed in the clinic and of course occupational therapy was also performed at home for the group, the subjects were blinded to what group they were in and They didn't know which group they were in. Occupational Therapy Intervention Providers: Given that pre and post-patient testing was performed by someone else, and we have used 4 different occupational therapists to intervene in this study, the intervention providers provided information on the patient's status at which stage of the disease were uninformed and did only the intervention and remained blind until after the analysis of the intervention. N/A Dementia. Intervention 1: Intervention group 1: Elderly with dementia to reduce cognitive impairment and increase motor skills for 6 weeks (12 one-hour sessions, 2 times a week) by occupational therapist, occupational therapy intervention to enhance cognitive skills, enhance daily life skills, they received reinforcement and facilitation of motor skills at home. Intervention 2: Control group 1: Elderly patients with dementia who received only medication.This group performed the relevant tests (before) and was again taken after 6 weeks of testing. Intervention 3: Intervention group 2: Informal caregivers received 12 sessions of occupational therapy on how to treat patients with dementia and raise awareness about the cause of patients' behavioral problems and provide adaptive strategies to better perform the caregiver role and also to restore caregiver balance. These 12 sessions were performed as the first 5 sessions in the clinic, 2 sessions at the patient's home, 4 sessions via telephone counseling and the last session again in the clinic. Intervention 4: Control group 2: caregivers of patients with dementia who did not receive any intervention. Yes - There is a plan to make this available What will be shared: Information on the main outcome, which is the purpose of the trial, will be shared for use in future studies. When: 6 months after analyzing and publishing the results To whom: Researchers and health policy makers Conditions: To be used in research and through citation studies Where to obtain: marjanghandi89@gmail.com How to obtain: After receiving the email, if reviewed and with the agreement of Kerman University of Medical Sciences, it will finally be emailed after 10 days. Comments:
public Dr.Mostafa Almasi Doughaee
No. 33, East Zartosht avenue, Valiasr street, Tehran
Tehran Iran (Islamic Republic of) 88802063 +98 21 8880 2063 A_mostafa108@yahoo.com Iran University of Medical Sciences scientific Dr. Malat Akbarfahimi
Maddarkaran St., Shahid Shah Nazari St., Mirdamad Boulevard, Tehran, Iran
تهران Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 malahatfahimi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 65 years Neurologist's diagnosis based on DSM-IV criteria for dementia Patients should be kept at home by official carers 65 years 90 years Both Relatively severe and severe dementia Patient's unwillingness and no cooperation to intervene F03.90 Unspecified dementia without behavioral disturbance Rehabilitation N/A Rehabilitation N/A Intervention group 1: Elderly with dementia to reduce cognitive impairment and increase motor skills for 6 weeks (12 one-hour sessions, 2 times a week) by occupational therapist, occupational therapy intervention to enhance cognitive skills, enhance daily life skills, they received reinforcement and facilitation of motor skills at home. Control group 1: Elderly patients with dementia who received only medication.This group performed the relevant tests (before) and was again taken after 6 weeks of testing. Intervention group 2: Informal caregivers received 12 sessions of occupational therapy on how to treat patients with dementia and raise awareness about the cause of patients' behavioral problems and provide adaptive strategies to better perform the caregiver role and also to restore caregiver balance. These 12 sessions were performed as the first 5 sessions in the clinic, 2 sessions at the patient's home, 4 sessions via telephone counseling and the last session again in the clinic. Control group 2: caregivers of patients with dementia who did not receive any intervention. Patient's cognition. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Addenbrooke ҆s Cognitive Examination. Cognitive evaluation of patients. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Mini-Mental State Examination. Patient Balance. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: BERG Balance Scale. Depression in patients with dementia. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Beck Depression Inventory ii. Anxiety in caregivers of patients with dementia. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Beck Anxiety Inventory. Caregiver Burden. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Caregiver Burden. The life balance structure of caregivers. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Life Balance Inventory. Social and emotional loneliness of caregivers. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Social and Emotional Loneliness Scale for Adults. Time management of caregivers. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Time Management Questionnaire. Social skills. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Disability Assessment For Dementia. Motor Abilities. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Timed “Up & Go” (TUG), Ten Meter , Chairstand, Barthel , Allen. Quality of Life. Timepoint: Before the intervention and 6 weeks after the start of occupational therapy. Method of measurement: Euro Qol- 5 Dimension (in patients) AND World Health Organization Quality of Life-BREF (in Caregivers). Kerman University of Medical Sciences Approved 2019-10-08 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman Kerman Kerman Iran (Islamic Republic of)