Home » Trials » SLCTR/2024/004
Effectiveness of maintenance cognitive stimulation therapy on cognitive function and electrophysiological markers among older adults with dementia : a randomized control trial.
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SLCTR Registration Number
SLCTR/2024/004
Date of Registration
The date of last modification
Feb 14, 2024
Scientific Title of Trial
Effectiveness of maintenance cognitive stimulation therapy on cognitive function and electrophysiological markers among older adults with dementia : a randomized control trial.
Public Title of Trial
Effectiveness of maintenance cognitive stimulation therapy (CST) on cognitive function, and frequency of EEG wave pattern in comparison to initial CST among older adults with mild to moderate dementia; A randomized control trial.
Disease or Health Condition(s) Studied
Dementia
Scientific Acronym
None
Public Acronym
None
Brief title
Universal Trial Number
U1111-1301-9833
Any other number(s) assigned to the trial and issuing authority
IRB3-113/2566 Faculty of Nursing, Burapha University
What is the research question being addressed?
What is the impact of maintenance cognitive stimulation therapy (CST) on cognitive function and frequency EEG wave pattern compared to initial CST alone among older adults with mild to moderate dementia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
This study will be undertaken in the government elderly nursing homes in Northeast region of Thailand. There are two steps in obtaining the sample for this study. A simple random sampling will be done by the RA during the first step to randomize one from three nursing homes. Then the elderly in the selected nursing home will be randomly assigned into experimental group and control group by using the coin tossing method. Participants in the intervention group will receive the initial cognitive stimulation therapy (CST), and the extension of the maintenance cognitive stimulation therapy (MCST) program. Participants in the control group will receive only the initial CST program, and usual care.
The MCST program includes the regular initial CST program along with an extension of the additional maintenance sessions. Hence there will be twice-a-week group interventions during the overall 15 weeks and this includes 30 themed sessions. The initial CST program consists of fourteen sessions which are 45-min sessions, held twice a week over 7 weeks. Also, an extension of the MCST program consists of a further sixteen, 45-min sessions, held twice a week over 8 weeks. These programs are designed using the theoretical concepts of reality orientation (RO)/cognitive stimulation. The intervention aims to improve cognitive function through a variety of cognitive tasks that involve executive function, multisensory stimulation, and reminiscence as an aid for orientation. The 14 themed sessions activities of the initial CST program include: 1) physical games, 2) sounds, 3) childhood memories, 4) food, 5) current affairs, 6) faces and scenes, 7) word association, 8) creativity, 9) categorizing objects, 10) orientation, 11) using money, 12) number games, 13) word games, and 14) team games. The 16 themed MCST sessions, in addition to the initial CST course, will run in the same way as the original CST course. Each session covers a different topic with a range of activities. The 16 themed sessions activities include: 1) my life (childhood), 2) current affairs (A), 3) current affairs (B), 4) using objects (A), 5) number game, 6) team games/quiz, 7) music session, 8) physical games, 9) categorizing objects, 10) using objects (B), 11) useful tips, 12) golden expressions cards (A), 13) golden expressions cards (B), 14) opinions on different types of art, 15) famous faces, and 16) word completion.
Activities of each session is as follows:
Session 1, 22: Physical games The researcher encourages the participants to introduce themselves to the group, mention their favorite team, meal, color, etc. Supporting self perception and playing catch with a ball until the music stops are also included.
Session 2, 21: Sounds and Music Matching the sounds (of creatures, objects, and so forth) with the relevant photographs, singing a song with or without anybody, moving an object (fork, spoon, etc.) with the beat of an instrumental.
Session 3, 15: Childhood memories Remembering the characteristics, moments, foods and games in childhood, encouraging the patients to talk, draw.
Session 4: Food Tasting and remembering foods with different tastes (e.g., jam, bread, chocolate, and yogurt), completing the food names, categorizing the foods, creating new names for food.
Session 5, 16, 17: Current affairs Making comments on the news in the newspapers, stating opinions, making comments on predetermined questions covering up-to-date issues.
Session 6, 29: faces and scenes Remembering the photographs of celebrities, archeological sites and historical places, making assessment about the photographs (who is older or where would you like to be?); Creating a moment relevant to the photographs and sharing this moment with the group.
Session 7, 30: Word association Completing the words (places, proverbs, celebrities, words indicating quantities, and so forth), and lyrics and melody of a song.
Session 8, 25, 28: Creativity and Useful tips Washing, peeling, chopping, mixing, and serving a fruit, making leaf prints, planting flowers in a pot.
Session 9, 18, 23: Categorizing objects Estimating the names in a certain category (eg, male names starting with A), writing on a board, categorizing the pictures in different categories by their colors, areas of usage, initials, and so forth.
Session 10: Orientation Asking questions to ensure orientation (categorizing by their colors, areas of usage, initials, etc), discussing on the old and new pictures of where they live or lived, asking questions about where they traveled.
Session 11, 24 : Using money and objects Estimating, reasoning, calculating and comparing the real and up-to-date prices of things (fruits, vegetables, beverages, stationery equipment, valuable objects, etc) to the old figures.
Session 12, 19: Number games Playing cards, estimating the card numbers, estimating the total sum of the money in a jar.
Session 13, 26, 27: Word games Reading stories/newspaper, playing hangman, doing puzzles, discussions etc.
Session 14, 20: Team games Creative activities: painting, coloring decorating, cooking, playing games with a team, rewarding the winning team.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Cognitive function assessed by the Alzheimer’s Disease Assessment Scale - Cognition Subscale (ADAS-Cog). The ADAS-Cog, is the standard cognitive test used in clinical trials for dementia. 11 tasks that include both subject-completed tests and observer-based assessments. Together these tasks assess the cognitive domains of memory, language, and praxis. Specific tasks include word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, and language. |
[ Week 0, 7, 15 ] |
Secondary outcome(s)
1.
Absolute (V2/Hz) power (AP) density, relative power (RP) density and spectral power (Power spectral) of the EEG wave form. |
[ Week 0, 7, 15 ] |
Target number/sample size
30 (15 in each arm)
Countries of recruitment
Thailand
Anticipated start date
2024-03-04
Anticipated end date
2024-06-14
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Regulatory approvals
Status
Approved
Date of Approval
2023-11-13
Approval number
IRB3-113/2566
Details of Ethics Review Committee
Name: | The ethics review committee of Institutional Review Board Graduate Studies, Faculty of Nursing, Burapha University |
Institutional Address: | Burapha University, 169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131 |
Telephone: | 0-3810-2222 |
Email: | 63810002@go.buu.ac.th |
Contact person for Scientific Queries/Principal Investigator
Wasan Gawgleun
Ph.D. candidate
Burapha University, 169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131
038102222
0898630630
038390351
63810002@go.buu.ac.th
https://www.buu.ac.th/
Contact Person for Public Queries
Dr. Pornchai Jullamate
Associate Professor and Dean
Burapha University, 169 Longhaad Bangsaen Road, Saensuk, Mueang, ChonBuri 20131
038102222
038390351
pornchai@buu.ac.th,
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results