Montessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan

Study Overview
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Brief Summary
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The study has both quantitative and qualitative components. The objective of the quantitative study is: To culturally adapt and refine Montessori activities for people living with dementia in Pakistan. To determine the feasibility and acceptability of culturally-adapted group based Montessori intervention for people with dementia in Pakistan. To build capacity and capability in dementia research (researcher training) The objective of the qualitative study is: To explore views on perceived effectiveness and sustainability of the study.

Detailed Description
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Pakistan is the sixth most populous country in the world. Mental health services are limited in Pakistan particularly older adults mental health services are almost nonexistent. According to a recent report in Pakistan currently 8 million people are of age 65 and above who have long term physical and psychological health conditions. This is a tough challenge for the country due to its poor economic condition.Hence, there is a need to develop programs that can help and improve the health-related quality of life of this population in low resource settings.We need to do a lot more work to address this issue. One possible low-cost, accessible, non-pharmacological intervention for BPSD (Behavioral Psychiatric symptoms of dementia) is the Montessori approach which is evidence based.The aim of the proposed project is to explore the feasibility and acceptability of using the Montessori intervention for people with dementia in Pakistan.

Official Title
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Montessori Intervention for Individuals With Dementia: A Feasibility Study

Conditions
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Dementia, Memory Impairment

Intervention / Treatment
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* Behavioral: Montessori Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with the following characteristics will be invited to participate in the study; Diagnosed with any type of dementia according to DSM V. Montreal Cognitive Examination Scale with a cutoff score 10 Age 60 years or older Residents of study catchment area Able to communicate in Urdu or English Not having any serious visual or hearing impairment Capacity to consent to study participation Willing to come to (care home, hospitals, research centre) for session. Willing to participate in up to 60 minutes session of the intervention, twice a week. Having a study partner (spouse or adult child caregiver) who agrees to participate in the study Exclusion Criteria: Participants with the following characteristics will not be eligible for the study; Advanced stage dementia Participants diagnosed with severe mental or physical illness which, in the judgement of the PI, precludes them from safely participating in the study. Unable to give consent to take part in the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: It's a single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montessori Intervention<br>Participants will receive Montessori intervention for three months,twice weekly sessions over the period of three months. | Behavioral: Montessori Intervention<br>* The Montessori method is a system of teaching developed by Maria Montessori based on principles to promote learning and independence in children. In the context of dementia care, this method has been tried in research settings in older people and was found to be effective in improving certain behavioral outcomes such as eating behaviors, agitation, and mood. The intervention is based on designing and offering activities that take into consideration the interests, needs, past experiences and preferences of participants. Importantly, participants demonstrating positive engagement with the intervention, suggesting that this may be a promising form of support to investigate and develop further for the care of people with dementia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of undertaking a trial of the intervention, as determined by: | Recruitment and attrition rates | 3rd month (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy logs | Acceptability and tolerability of the intervention | 3rd month (post intervention) | 
| Montreal Cognitive Examination: | It assesses different cognitive domains, attention and concentration, executive functions, memory, language, visuo constructional skills, conceptual thinking, calculation and orientation. Score >26 shows cognitive impairment.(Nasreddine et al., 2005) | Changes from baseline to 3rd month | 
| Quality of life assessment in Dementia DEMQol | It's a 28 item self-report questionnaire for people with dementia. It inquires about feelings, memory, and everyday life of the people with dementia. Score ranges from 28-112 with four-point Likert scale (1 = a lot, 2 = quite a bit, 3 = a little, 4 = not at all) for responses. (Smith et al., 2005) | Changes from baseline to 3rd month outcome | 
| Geriatric Depression Scale | It comprises of 15 items on which a score of >5 is suggestive of depression and a score of greater than or equal to 10 is indicative of depression.(Almeida & Almeida, 1999) | Changes from baseline to 3rd month outcome | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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memory impairment, montessori intervention, neurocognitive disorder