Back to resultsMontessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan
Primary Purpose
Dementia, Memory Impairment
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Montessori Intervention
Sponsored by
About this trial
This is an interventional other trial for Dementia focused on measuring memory impairment, montessori intervention, neurocognitive disorder
Eligibility Criteria
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
Sites / Locations
- Darul Skoun (Older Adult care home)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Montessori Intervention
Arm Description
Participants will receive Montessori intervention for three months,twice weekly sessions over the period of three months.
Outcomes
Primary Outcome Measures
Feasibility of undertaking a trial of the intervention, as determined by:
Recruitment and attrition rates
Secondary Outcome Measures
Therapy logs
Acceptability and tolerability of the 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)
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)
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)
Full Information
NCT ID
NCT03491774
First Posted
April 2, 2018
Last Updated
March 19, 2019
Sponsor
Pakistan Institute of Living and Learning
1. Study Identification
Unique Protocol Identification Number
NCT03491774
Brief Title
Montessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan
Official Title
Montessori Intervention for Individuals With Dementia: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Memory Impairment
Keywords
memory impairment, montessori intervention, neurocognitive disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It's a single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montessori Intervention
Arm Type
Experimental
Arm Description
Participants will receive Montessori intervention for three months,twice weekly sessions over the period of three months.
Intervention Type
Behavioral
Intervention Name(s)
Montessori Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of undertaking a trial of the intervention, as determined by:
Description
Recruitment and attrition rates
Time Frame
3rd month (post intervention)
Secondary Outcome Measure Information:
Title
Therapy logs
Description
Acceptability and tolerability of the intervention
Time Frame
3rd month (post intervention)
Title
Montreal Cognitive Examination:
Description
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
Title
Quality of life assessment in Dementia DEMQol
Description
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
Title
Geriatric Depression Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Darul Skoun (Older Adult care home)
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Montessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan
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