Clinical trial NCT03491774: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Memory Impairment
Keywords: memory impairment, montessori intervention, neurocognitive disorder
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It's a single arm study
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Feasibility of undertaking a trial of the intervention, as determined by:
timeFrame: 3rd month (post intervention)
Secondary outcomes:
measure: Therapy logs
timeFrame: 3rd month (post intervention)
measure: Montreal Cognitive Examination:
timeFrame: Changes from baseline to 3rd month
measure: Quality of life assessment in Dementia DEMQol
timeFrame: Changes from baseline to 3rd month outcome
measure: Geriatric Depression Scale
timeFrame: Changes from baseline to 3rd month outcome
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Darul Skoun (Older Adult care home)
state: Sindh
Study officials:
References: