- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01818778
The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes (VolCogStim)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Older adults who maintain their cognitive skills and abilities are able to live more independently than those whose skills have deteriorated. The costs (money, time, personnel) associated with providing cognitive stimulation programs to residents in long-term care homes often prohibit the delivery of these programs. The present study explored the efficacy of using volunteers to administer a stimulation program in two long-term care homes. The program focused on stimulating reasoning, attention, and memory abilities using uncomplicated, pen-and-paper exercises. Thirty-six resident participants and 16 volunteer participants were randomly assigned to one of two parallel groups, either the control or stimulation group.
For eight weeks, three times each week, control group participants met for standard "friendly visits" (casual conversation between a resident and volunteer) and stimulation group participants met to work through a variety of exercises meant to stimulate the cognitive abilities of residents. Results were analyzed using a 2-way ANOVA and indicated statistically significant Group x Time interactions for Verbal Memory (F(1, 33) = 7.92, p = .008), Non-Verbal Memory (F(1, 33) = 6.8, p = .014), Learning (F(1, 33) = 5.27, p = .028), and Verbal Fluency (F (1, 33) = 5.56, p = .024).
Volunteers completed a post-study questionnaire which indicated that the volunteers in the stimulation group found their skills-based interactions more stimulating for residents. Given this showing of improved resident abilities, it is reasonable to assert that the study does demonstrate that a volunteer-administered, cognitive stimulation program can provide measurable gains in the cognitive abilities of older adults. Further studies concerning the role of volunteers in the maintenance of the cognitive abilities of older adults are recommended.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6A 2E1
- Baycrest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65 years and over
- living in a long-term care home
- normal or corrected visual and auditory acuity
- English proficiency
- not currently using de-stabilizing, psychotropic medication known to impair cognition
- ability and willingness to actively listen to and accurately follow 2-step instructions for at least 20 consecutive minutes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stimulation Group
Cognitive Stimulation Group: One-on-one (one volunteer visiting one resident at a time), stimulation-group residents and stimulation-group volunteers met 3 times each week, for 8 weeks, to work through a variety of memory, reasoning, and selective attention exercises.
Each visit was 20 minutes in length.
|
The stimulation program was composed of therapy- and education-based exercises which were specifically designed to stimulate reasoning, memory, and attention skills in adults.
|
Active Comparator: Control Group
Standard "Friendly Visit": Control-group residents and control-group volunteers, one-on-one, met for 8 weeks, 3 times each week, for "friendly visits".
Each visit was 20 minutes in length.
|
Volunteers provided standard "friendly visits" to residents which included a friendly greeting and casual conversation about issues which interest the resident.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test of Memory and Learning - Senior Edition (TOMAL-SE)
Time Frame: 10 weeks
|
The TOMAL-SE was designed specifically for seniors and provides a thorough assessment, without being fatiguing (Reynolds & Vorees, 2012).
The battery includes normative data for ages 55:0-89:11.
It is a paper-based test and takes approximately 25-35 minutes to administer.
It provides scores for the following indexes: Verbal Memory, Non-Verbal Memory, Delayed Memory, and Learning.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II; Wechsler, 2011)
Time Frame: 10 weeks
|
The WASI-II is designed to measure intelligence.
The latest version, published in 2011, includes normative data for ages 6:0-90:11 years.
The paper-based, two-subtest form includes the Vocabulary and Matrix Reasoning tests and provides an estimate of general cognitive ability.
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Letter Sorting Test
Time Frame: 10 weeks
|
This test assesses working memory and concentration.
Participants were asked to spell a 5-digit word, forwards, backwards, and in alphabetical order.
To score the test, 1 point each was given for spelling the word correctly forwards, backwards and in alphabetical order.
The test usually took approximately 2 minutes to administer.
|
10 weeks
|
Clock Drawing Test
Time Frame: 10 weeks
|
In this test, participants were given a sheet of paper with a circle on it.
They were then be asked to follow a two-step instruction: "This is a clock.
Please draw all the numbers on it and the time 'ten past eleven'".
This test was originally developed to assess visuo-constructional abilities, but it also requires language comprehension, numerical knowledge, strategy planning, and memory.
To score the test, the 6-point Shulman et al. (1993) scoring method will be employed where higher scores reflect a greater number of errors and more impairment.
The test took approximately 2 minutes to complete.
|
10 weeks
|
Action "Verbal Fluency" Test
Time Frame: 10 weeks
|
A test of action verbal fluency was applied to measure working memory, planning, organization, and word retrieval.
Residents were asked to generate as many action words, in their infinitive form (i.e., eat, smell, etc.) as possible within 60 seconds.
One point was given for each action word stated.
Verbal instructions explicitly stated that no points would be awarded for the use of the same word with different endings, like eat, eating, and eaten.
The test took approximately 1-2 minutes to administer.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John Kirby, Ph.D., Queen's University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Queens-Baycrest 65
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Geriatric Disorder
-
Centre Hospitalier Universitaire de NiceUnknown
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Nantes University HospitalCompleted
-
University of ValenciaUnknownGeriatric DisorderSpain
-
The Hong Kong Polytechnic UniversityShatin HospitalUnknown
-
Tel-Aviv Sourasky Medical CenterUnknownGeriatric DisorderIsrael
-
University Hospital, GrenobleCompletedGeriatric Disorder | Mobil UnitFrance
-
Washington University School of MedicineCompletedCancer | Geriatric Disorder | Patient FallUnited States
-
University of AarhusCompleted
Clinical Trials on Cognitive stimulation program
-
Badalona Serveis AssistencialsPublic Health Agency of Barcelona; Reality Telling SLCompletedCognitive Dysfunction | Mild Cognitive ImpairmentSpain
-
Escola Superior de Enfermagem de CoimbraGrouping of Health Centers of Greater Porto I - Santo Tirso/Trofa; Group of...UnknownNeurocognitive Disorders | DementiaPortugal
-
Universidad Nacional Autonoma de MexicoRecruitingTelerehabilitation | Neuropsychology | HIV DementiaMexico
-
University Hospital, AngersNot yet recruitingDysexecutive Mild Cognitive ImpairmentFrance
-
Universidad de ZaragozaNot yet recruitingCognitive Dysfunction | Mild Cognitive Impairment
-
University of BarcelonaMinisterio de Economía y Competitividad, SpainCompleted
-
heba ahmed khalifaActive, not recruitingDiabetic Peripheral NeuropathyEgypt
-
NYU Langone HealthStony Brook UniversityCompleted
-
NYU Langone HealthWithdrawnMultiple Sclerosis
-
Washington University School of MedicineNational Institutes of Health (NIH)Completed