Montessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan
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|ClinicalTrials.gov Identifier: NCT03491774|
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia Memory Impairment||Behavioral: Montessori Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||It's a single arm study|
|Masking:||None (Open Label)|
|Official Title:||Montessori Intervention for Individuals With Dementia: A Feasibility Study|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
Experimental: Montessori Intervention
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: [ Time Frame: 3rd month (post intervention) ]Recruitment and attrition rates
- Therapy logs [ Time Frame: 3rd month (post intervention) ]Acceptability and tolerability of the intervention
- Montreal Cognitive Examination: [ Time Frame: Changes from baseline to 3rd month ]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)
- Quality of life assessment in Dementia DEMQol [ Time Frame: Changes from baseline to 3rd month outcome ]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)
- Geriatric Depression Scale [ Time Frame: Changes from baseline to 3rd month outcome ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491774
|Darul Skoun (Older Adult care home)|
|Karachi, Sindh, Pakistan|