Effects of an Integrative Learning Program on Community Dwelling Old People With Dementia

NCT04620083 | Completed

• 1 other identifier: 2020_CTS001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To develop an integrative learning program and evaluate its effect on people with dementia. Methods: The study started from January 2017 to March 2018 and consisted of two stages. The first stage employed Delphi technique while the second an experimental design. An expert panel was invited to develop the integrative learning program based on the neuroplasticity and learning framework in the first stage. A mixed method approach was adopted for the evaluation of the program in the second stage. Questionnaires and clinical instruments were used to collect quantitative data. For qualitative data, verbatim transcripts of case conferences were coded, analyzed, and collapsed into themes and sub-themes by consensus. Results: Quantitatively, significant improvements in the participants' functional performance and well-being in the experimental groups, while qualitatively, improvements on their communications, emotions, connectedness with self and others, and well-being. Conclusion: Overall the evaluation was positive; however, larger sample size of old people from more community care centers would provide more conclusive results.

Conditions

Dementia

Keywords

Dementia; Neuroplasticity; Integrative Learning; Slow Stream Rehabilitation; Novice-expert Continuum; Community Dwelling Old People

Outcome Measures

Primary Outcomes (4)

• Change from baseline disability level due to dementia at 3 months

  By Functional Assessment Stage Test, the minimum is Stage 1 (Normal Aging) and the maximum is Stage 7f (Severe Dementia), the lower is the better

  Up to 3 months

• Change from baseline disability level due to dementia at 6 months

  By Functional Assessment Stage Test, the minimum is Stage 1 (Normal Aging) and the maximum is Stage 7f (Severe Dementia), the lower is the better

  Up to 6 months

• Change from baseline cognitive function impairment due to dementia at 3 months

  By Montreal Cognitive Assessment - Hong Kong Version, the minimum is 0 score and the maximum is 30, a score of 26 or over is considered to be normal, the higher is the better

  Up to 3 months

• Change from baseline cognitive function impairment due to dementia at 6 months

  By Montreal Cognitive Assessment - Hong Kong Version, the minimum is 0 score and the maximum is 30, a score of 26 or over is considered to be normal, the higher is the better

  Up to 6 months

Secondary Outcomes (16)

• Change from baseline functional independence at 3 months

  Up to 3 months

• Change from baseline functional independence at 6 months

  Up to 6 months

• Change from baseline mobility function at 3 months

  Up to 3 months

• Change from baseline mobility function at 6 months

  Up to 6 months

• Change from baseline static balance and fall risk at 3 months

  Up to 3 months

Study Arms (3)

Control Group

NO INTERVENTION

For the control group, the participants received conventional therapy which included group activities for reality orientation, reminiscence therapy and activities organized by occupational therapists one hour a day, five days a week.

Experimental 3-day Normal Group

EXPERIMENTAL

In addition to conventional therapy, the participants in this experimental groups also joined the integrative learning program for 3 days per week.

Other: Integrative Learning Program for Old People with Dementia

Experimental 5-day Intensive Group

EXPERIMENTAL

In addition to conventional therapy, the participants in this experimental groups also joined the integrative learning program for 5 days per week. For consistency, Day 1 and 3 of the 3-day protocol were replicated as Day 4 and Day 5 of the 5-day protocol.

Other: Integrative Learning Program for Old People with Dementia

Interventions

Integrative Learning Program for Old People with Dementia OTHER

The program included modalities for reality orientation, daily living skills training, reminiscence therapy, multisensory stimulation, fall prevention program, mindfulness activities, Meridian exercise, brain health program (Four Arts of the Chinese Scholar which referred to zither, go, calligraphy and painting) and health education. It was also agreed that case managers, caregivers, and participants were free to choose these treatments or could be assigned to a treatment regime on a 'mix and match' basis to suit their personality traits for improving their abilities to meet their own needs. This program was developed by the team using Delphi technique.

Experimental 3-day Normal Group; Experimental 5-day Intensive Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• People aged 65 or above
• Members of the community care centers
• Diagnosed with dementia and mild cognition impairment (determined by the Montreal Cognitive Assessment Test for Dementia, MoCA score 12.7-20.1 depending on education level)

You may not qualify if:

• Living alone
• With communication difficulties like language barriers, deafness, dysphasia and/or severe dysarthria
• Recently participated in another dementia program
• With known history of psychotic illnesses such as schizophrenic, psychiatric, or with organic brain diseases such as brain tumors

Sponsors & Collaborators

• Education University of Hong Kong: lead
• Guangzhou Medical University: collaborator
• Guangzhou University of Chinese Medicine: collaborator
• Tung Wah College: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Hong Kong Nang Yan College of Higher Education: collaborator
• Ginger Knowledge Transfer and Consultancy Limited: collaborator

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Allocation concealment was done to avoid selection bias while blinding was done to research assistant who performed data collection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The research team randomly allocated the elderly to the control group (Con), Experimental 3-day normal group (Exp-N) and Experimental 5-day intensive group (Exp-I). For the control group, the participants received conventional therapy which included group activities for reality orientation, reminiscence therapy and activities organized by occupational therapists one hour a day, five days a week. In addition to conventional therapy, the two experimental groups also joined the integrative learning program. For consistency, Day 1 and 3 of the 3-day protocol were replicated as Day 4 and Day 5 of the 5-day protocol.

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 6, 2020
• Study Start: May 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: March 31, 2018
• Last Updated: November 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)