Skip to main content
OpenTrials
Completed

NCT Number: NCT03491774

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Memory Disorders Memory Impairment Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Darul Skoun (Older Adult care home)

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3rd month (post intervention)

    Recruitment and attrition rates

Secondary outcomes

  1. Therapy logs

    Time frame: 3rd month (post intervention)

    Acceptability and tolerability of the intervention

  2. Montreal Cognitive Examination:

    Time frame: 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)

  3. Quality of life assessment in Dementia DEMQol

    Time frame: 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)

  4. Geriatric Depression Scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

Montessori Intervention for Individuals With Dementia: A Feasibility Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 9, 2018
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.