An interventional study of Montessori Intervention in Dementia and Memory Impairment, sponsored by Pakistan Institute of Living and Learning. Completed at 1 site in Pakistan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Other
The study has both quantitative and qualitative components.
The objective of the quantitative study is:
The objective of the qualitative study is:
To explore views on perceived effectiveness and sustainability of the study.
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.
2,373 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 24 is below the median of 90 across 1,759 interventional studies indexed under Dementia.
Browse Dementia studies →Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.
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Participants with the following characteristics will be invited to participate in the study;
Exclusion Criteria:
Participants with the following characteristics will not be eligible for the study;
Participants will receive Montessori intervention for three months,twice weekly sessions over the period of three months.
Behavioral: Montessori Intervention
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.
Feasibility of undertaking a trial of the intervention, as determined by:
Recruitment and attrition rates
Time frame: 3rd month (post intervention)
Therapy logs
Acceptability and tolerability of the intervention
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Changes from baseline to 3rd month outcome
Ran from May 2018 to primary completion in Dec 2018, 7 months.
Of 858 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 7 months is below that.
Counting every sponsor, half of 904 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Pakistan Institute of Living and Learning