DementiaNCT03491774
Montessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan
A study testing Montessori Intervention in people with Dementia and Memory Impairment, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Memory Impairment
- What is being tested?
- Montessori Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Montessori Intervention for Individuals With Dementia: A Feasibility Study
The study has both quantitative and qualitative components.
The objective of the quantitative study is:
- To culturally adapt and refine Montessori activities for people living with dementia in Pakistan.
- To determine the feasibility and acceptability of culturally-adapted group based Montessori intervention for people with dementia in Pakistan.
- 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.
Read the 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.
- Conditions
- Dementia, Memory Impairment
- Being tested
- Montessori Intervention
- Keywords
- memory impairment, montessori intervention, neurocognitive disorder
- Medical subject headings
- Dementia, Memory Disorders, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montessori InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Montessori Intervention | Experimental | Participants will receive Montessori intervention for three months,twice weekly sessions over the period of three months. Receives: Behavioral: Montessori Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of undertaking a trial of the intervention, as determined by:
Recruitment and attrition rates
Measured: 3rd month (post intervention)
Secondary outcomes (4)
Therapy logs
Acceptability and tolerability of the intervention
Measured: 3rd month (post intervention)
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)
Measured: Changes from baseline to 3rd month
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)
Measured: Changes from baseline to 3rd month outcome
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)
Measured: Changes from baseline to 3rd month outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 May 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It's a single arm study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491774
- Sponsor's protocol ID
- PILL-Montessori Dementia
- Status last verified
- Mar 2019
- First submitted
- 2 Apr 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montessori Intervention for Individuals With Dementia: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03491774
- Acronym / sponsor ID
- PILL-Montessori Dementia
- Conditions
- Dementia, Memory Impairment
- Keywords
- memory impairment, montessori intervention, neurocognitive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has both quantitative and qualitative components.
The objective of the quantitative study is:
- To culturally adapt and refine Montessori activities for people living with dementia in Pakistan.
- To determine the feasibility and acceptability of culturally-adapted group based Montessori intervention for people with dementia in Pakistan.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It's a single arm study
| Arm | Type | Receives |
|---|---|---|
| Montessori Intervention | Experimental | Behavioral: Montessori InterventionParticipants will receive Montessori intervention for three months,twice weekly sessions over the period of three months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants with the following characteristics will be invited to participate in the study;
Key exclusion criteria (4 listed)
- Participants with the following characteristics will not be eligible for the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montessori InterventionThe 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. | Behavioural | Montessori Intervention |
Primary outcome
Feasibility of undertaking a trial of the intervention, as determined by:
Time frame: 3rd month (post intervention)
Recruitment and attrition rates
4 secondary outcomes
Therapy logs
Time frame: 3rd month (post intervention)
Montreal Cognitive Examination:
Time frame: Changes from baseline to 3rd month
Quality of life assessment in Dementia DEMQol
Time frame: Changes from baseline to 3rd month outcome
Geriatric Depression Scale
Time frame: Changes from baseline to 3rd month outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montessori Intervention in people with Dementia and Memory Impairment, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of undertaking a trial of the intervention, as determined by: (time frame: 3rd month (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.