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Clinical Trials/NCT03491774
NCT03491774CompletedNot Applicable

Montessori Intervention for Individuals With Dementia: A Feasibility Study

Pakistan Institute of Living and Learning1 site in 1 country24 target enrollmentStarted: May 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Feasibility of undertaking a trial of the intervention, as determined by:

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Montessori Intervention

Experimental

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

Intervention: Montessori Intervention (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 3rd month (post intervention)

Recruitment and attrition rates

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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