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IRCT20191105045337N1 IRCT 2020-10-11 Iran University of Medical Sciences The Effect of Educational Program of Sensory Processing strategies on Behavior and Functional Disability of people with Dementia Designing Caregiver Centered Program Based on Dunn’s Sensory Processing Model, and Defining Its Efficacy on Functional Disability and Behavior Dimensions in People with Dementia 2020-09-22 anticipated 30 Complete https://irct.ir/trial/43682 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants were randomly divided into control and treatment groups. A simple randomization method will be used. Randomization based on a single sequence of random allocations is called simple randomization. A simple randomization of the most common methods used implement a random process. In this way there is a high probability of equal distribution of individuals assigned to each group, especially in studies with a small sample size. However, according to the probable hypothesis, with increasing the sample size, this inequality is greatly reduced. A table of random numbers will be used for randomization. The table of random numbers is a set of numbers that are produced without a specific pattern or order and in a completely random way. To use a random number table, the researcher first determines how to read the numbers (eg, top, bottom, left, or right). The second prerequisite is the researcher's consideration of numbers for different groups (for example, even numbers for intervention group and individual numbers for control group). The researcher then touches one of the numbers and moves in one of the predetermined directions, record the numbers and assign them to different groups, Blinding description: Participants (caregivers of people with dementia) and assessor (responsible for data collection and outcome assessors) are blind. In this way, caregivers who are the main participants fall into two groups. Both groups receive training brochures on sensory processing strategies. In addition, both the intervention group and the control group have routine treatments. But in the intervention group, in addition to the above, caregivers also benefit from training sessions related to caregiver-specific sensory processing strategies. In this way, the participants are blind to the treatment and control group. The assessor (responsible for data collection and outcome assessor) is also kept blind to the information of the treatment and control group. N/A Dementia, vascular Dementia, Alzheimer Disease. Intervention 1: Intervention group: The Intervention group will receive interventions in two sessions of group caregiver training and several sessions of individual training. Group training sessions: During these sessions, the therapist will use the designed training guide to describe the nervous system stimulation threshold, the arousal state (high response to low response), and the sensory processing pattern and analyze the behavioral problems of dementia patients. In these sessions, the therapist will encourage caregivers to address patients' behavioral problems and participate in group interactions. The therapist will transfer knowledge and make information meaningful to caregivers by explaining how these patterns affect people's daily activities, explaining how the environment and activities are adapted, and expressing self-regulatory strategies (calming and alert activities). Individual training sessions: After the group training sessions, the therapist will meet with each of the caregivers during which training interventions strategies will be developed for each of the sensory processing disorder patterns. Training methods include a review of the sensory processing disorder pattern and clear and concise explanations of intervention patterns related to the disorder pattern (using educational slides, brochures, videos, etc.) and guidance on applying these strategies to suit the context and context of the place of residence. Intervention 2: Control group: This group receives routine occupational therapy interventions. These interventions include cognitive interventions, sensory-motor interventions that performed by a therapist at the Alzheimer's Association. In this group, patients receive interventions in the form of regular sessions by the therapist. Yes - There is a plan to make this available What will be shared: Participants' personal data (All information including main or sub-information) is shared, although all data can be shared after people have not been identified. When: It will be available six months after the release of the results. To whom: Researchers working at academic and scientific institutions and those working in dementia-related medical centers can apply for the data. Conditions: The use of datas for treatment, counseling, etc... to caregivers or people with dementia is allowed in scientific and medical centers. Where to obtain: 1. Dr. afsoon hasani mehraban: email address: afsoonmehraban@hotmail.com 2. Dr. laleh lajevardi: email address: laleh23275@yahoo.com 3. masoome zaree: email address: masoomezaree@gmail.com How to obtain: 1. Refer to one of the three people introduced via email or in person 2. Confirmation of the identity of the client by the team members 3. Specifying the purpose of the data request, For what purposes and for what purpose it will be used. 4. After reviewing the above, it will be provided to the applicant. Comments:
public Afsoon Hasani Mehraban
Faculty of Rehabilitation Sciences, Madazkaran St., Shah Nazari St., Mirdamad, Tehran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 2059 afsoonmehraban@hotmail.com Iran University of Medical Sciences scientific Massome Zaree
Faculty of Rehabilitation Sciences, Madazkaran St., Shah Nazari St., Mirdamad, Tehran
Tehran Iran (Islamic Republic of) 15459-13487 009822222059 masoomezaree@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Dementia diagnosis based on medical records of patients and approved by DSM-V criteria by psychiatrist or neurologist (Alzheimer's or vascular type of dementia). Presence of at least one pattern of Sensory Processing disorders based on the Adolescent /Adult Sensory Profile. The severity of dementia will be determined after pilot test of the sensory processing intervention program. No other psychiatric disorders. caregivers must dominate to Persian. MMSE Twenty-Three and Up for Caregivers (to determine caregivers' ability to apply sensory processing interventions). 60 years no limit Both A patient with other types of dementia. The patient does not have any of the Sensory Processing disorders. A patient with other psychiatric disorders. F01 Dementia Rehabilitation Rehabilitation Intervention group: The Intervention group will receive interventions in two sessions of group caregiver training and several sessions of individual training. Group training sessions: During these sessions, the therapist will use the designed training guide to describe the nervous system stimulation threshold, the arousal state (high response to low response), and the sensory processing pattern and analyze the behavioral problems of dementia patients. In these sessions, the therapist will encourage caregivers to address patients' behavioral problems and participate in group interactions. The therapist will transfer knowledge and make information meaningful to caregivers by explaining how these patterns affect people's daily activities, explaining how the environment and activities are adapted, and expressing self-regulatory strategies (calming and alert activities). Individual training sessions: After the group training sessions, the therapist will meet with each of the caregivers during which training interventions strategies will be developed for each of the sensory processing disorder patterns. Training methods include a review of the sensory processing disorder pattern and clear and concise explanations of intervention patterns related to the disorder pattern (using educational slides, brochures, videos, etc.) and guidance on applying these strategies to suit the context and context of the place of residence. Control group: This group receives routine occupational therapy interventions. These interventions include cognitive interventions, sensory-motor interventions that performed by a therapist at the Alzheimer's Association. In this group, patients receive interventions in the form of regular sessions by the therapist. Behavior. Timepoint: before intervention and 1, 2 , 4 weeks after intervention. Method of measurement: Adolescent / Adult Sensory Profiles are designed to examine Behavioral responses to daily sensory experiences for individuals 11 years and older (Dunn and Brown, 2001). Items in this tool are organized according to the categories of sensory processing: taste/ smell, motion (vestibular/ deep), vision, tactile, level of activity and hearing. Item components (60 items) provide information about quadrants (low registration, sensory seeking, sensory sensitivity, sensory avoidance) based on Dunn's sensory processing model, sensory processing classifications, neural threshold continuum (above/ Bottom) and self-regulation strategies (passive / active). Functional Disability. Timepoint: before intervention and 1, 2 , 4 weeks after intervention. Method of measurement: The Disability Assessment of Dementia was designed to measure Functional ability in dementia in 1999 by Gelinas et al. This scale is based on the WHO Health Model. BADL, IADL, and Cognitive Skills, including starting, planning, organizing, and applying them effectively, are assessed at this scale. In total, it consists of 40 items, 17 items related to BADL and 23 items to IADL, which summarize the individual's performance over the past two weeks through a brief interview with the caregiver. Scoring items includes answers to yes: 1, no: 2 and useless. This scale was evaluated in 2016 by Soltani et al. And its validity and reliability were evaluated. Internal consistency was 0.78 for this scale and 0.99 for test-retest and test-retest reliability values. Burden of Care. Timepoint: before intervention and 1, 2 , 4 weeks after intervention. Method of measurement: The Burden of Care questionnaire for people with dementia is a 29-item scale designed in 2010 to assess the burden of care in Iran with respect to cultural context, test-retest reliability and internal consistency reliability of this scale were 0.94, respectively. And 0.97 reported. Cognition of dementia patients. Timepoint: before intervention and 1, 2 , 4 weeks after intervention. Method of measurement: The Montreal Cognitive Assessment Scale measures short-term memory, visual and spatial ability, executive performance, verbal fluency, and verbal abstraction task. The sensitivity of this scale was also reported in those with mild cognitive impairment 0.9 and those with Alzheimer's 100%. The Persian version of this scale was developed in 2010 by Amsaki and colleagues in people with Parkinson's disease. Internal consistency was 0.77 and sensitivity was 0.85. Iran University of Medical Sciences Approved 2019-12-01 Ethics committee of Iran University of Medical Sciences Fifth Floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway between Chamran and Sheikh Fazlollah, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)