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

Dementia Clinical Trial

Official title:

Montessori Intervention for Individuals With Dementia: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491774
• Other study ID #: PILL-Montessori Dementia
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2019
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Memory Disorders
• Memory Impairment

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Darul Skoun (Older Adult care home)	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of undertaking a trial of the intervention, as determined by:	Recruitment and attrition rates	3rd month (post intervention)
Secondary	Therapy logs	Acceptability and tolerability of the intervention	3rd month (post intervention)
Secondary	Montreal Cognitive Examination:	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)	Changes from baseline to 3rd month
Secondary	Quality of life assessment in Dementia DEMQol	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)	Changes from baseline to 3rd month outcome
Secondary	Geriatric Depression Scale	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)	Changes from baseline to 3rd month outcome