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

Not Applicable

Completed

• Conditions: Dementia; Memory Impairment
• Interventions: Behavioral: Montessori Intervention

• Registration Number: NCT03491774
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-09
• Study Start: 2018-05-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of undertaking a trial of the intervention, as determined by:	3rd month (post intervention)	Recruitment and attrition rates

Secondary Outcome Measures

Name	Time	Method
Therapy logs	3rd month (post intervention)	Acceptability and tolerability of the intervention
Montreal Cognitive Examination:	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)
Quality of life assessment in Dementia DEMQol	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)
Geriatric Depression Scale	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)

Trial Locations

Locations (1)

Darul Skoun (Older Adult care home); 🇵🇰 Karachi, Sindh, Pakistan