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

NCT03491774 | Completed

• 1 other identifier: PILL-Montessori Dementia
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study has both quantitative and qualitative components. The objective of the quantitative study is:

1. 1.To culturally adapt and refine Montessori activities for people living with dementia in Pakistan.
2. 2.To determine the feasibility and acceptability of culturally-adapted group based Montessori intervention for people with dementia in Pakistan.
3. 3.To build capacity and capability in dementia research (researcher training)

Conditions

Dementia; Memory Impairment

Keywords

memory impairment, montessori intervention, neurocognitive disorder

Outcome Measures

Primary Outcomes (1)

• Feasibility of undertaking a trial of the intervention, as determined by:

  Recruitment and attrition rates

  3rd month (post intervention)

Secondary Outcomes (4)

• Therapy logs

  3rd month (post intervention)

• Montreal Cognitive Examination:

  Changes from baseline to 3rd month

• Quality of life assessment in Dementia DEMQol

  Changes from baseline to 3rd month outcome

• Geriatric Depression Scale

  Changes from baseline to 3rd month outcome

Study Arms (1)

Montessori Intervention

EXPERIMENTAL

Participants will receive Montessori intervention for three months,twice weekly sessions over the period of three months.

Behavioral: Montessori Intervention

Interventions

Montessori Intervention BEHAVIORAL

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.

Montessori Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Darul Skoun (Older Adult care home)

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Dementia; Memory Disorders; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It's a single arm study

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

PA (1)