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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491774
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Brief Summary:

The study has both quantitative and qualitative components.

The objective of the quantitative study is:

  1. To culturally adapt and refine Montessori activities for people living with dementia in Pakistan.
  2. To determine the feasibility and acceptability of culturally-adapted group based Montessori intervention for people with dementia in Pakistan.
  3. 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

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.

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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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Memory

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Feasibility of undertaking a trial of the intervention, as determined by: [ Time Frame: 3rd month (post intervention) ]
    Recruitment and attrition rates


Secondary Outcome Measures :
  1. Therapy logs [ Time Frame: 3rd month (post intervention) ]
    Acceptability and tolerability of the intervention

  2. 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)

  3. 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)

  4. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Pakistan
Darul Skoun (Older Adult care home)
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning

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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT03491774    
Other Study ID Numbers: PILL-Montessori Dementia
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pakistan Institute of Living and Learning:
memory impairment, montessori intervention, neurocognitive disorder
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders