The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Facilities (VolCogStim)

This study is not yet open for participant recruitment.
Verified March 2013 by Queen's University
Sponsor:
Collaborator:
Baycrest
Information provided by (Responsible Party):
Dr. John Kirby, Queen's University
ClinicalTrials.gov Identifier:
NCT01818778
First received: March 19, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

Seniors who maintain their cognitive skills and abilities are able to live more independently than seniors whose skills have deteriorated. The costs associated with providing cognitive stimulation and training programs to residents in long-term care facilities often prohibit the delivery of these programs. The present study explores the efficacy of using volunteers to administer a cognitive stimulation program to residents in two long-term care facilities. The cognitive program will focus on stimulating memory, reasoning, and attention skills. Participants and volunteers will be assigned randomly into one of two groups and receive either a regular "friendly visit" (casual conversation with a volunteer - the control group) or a skills-based visit (explicit instruction in skills building - the stimulation group). Pre- and post-test results will be compared between residents in each group. The volunteers will be trained to provide the specific stimulation activities and volunteer feed-back will be reviewed to provide insight into the practicality of implementing such a program within the context of long-term care facilities. It is hypothesized that seniors in the stimulation group will demonstrate measurably improved skills.


Condition Intervention
Impaired Cognition
Geriatric Disorder
Learning Disorders
Age-Related Memory Disorders
Impairment of Attention
Other: Cognitive stimulation program
Other: Standard "Friendly Visit"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Facilities

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Test of Memory and Learning - Senior Edition (TOMAL-SE) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    The TOMAL-SE was designed specifically for seniors and provides a thorough assessment without being fatiguing. 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 (Reynolds & Vorees, 2012). It includes six core subtests and three delayed recall tasks that evaluate general and specific memory functions. The standardized assessment yields three core memory indexes: Verbal Memory, Nonverbal Memory, and Composite Memory.


Secondary Outcome Measures:
  • Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II; Wechsler, 2011) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Letter Sorting Test [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    This test assesses working memory and concentration. Subjects are asked to spell a 5-digit word, forwards, backwards, and in alphabetical order. To score the test, 1 point each is given for spelling the word correctly forwards, backwards and in alphabetical order. The test usually takes approximately 2 minutes to administer.

  • Clock Drawing Test [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    In this test, residents will be given a sheet of paper with a circle on it. They will 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 takes approximately 2 minutes to complete.

  • Action "Verbal Fluency" Test [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    A test of action verbal fluency will be applied to measure working memory, planning, organization, and word retrieval. Residents will be asked to generate as many action words, in their infinitive form (i.e., eat, smell, etc.) as possible within 60 seconds. One point is given for each action word stated. Verbal instructions will explicitly state that no points will be awarded for the use of the same word with different endings, like eat, eating, and eaten. The test takes approximately 1-2 minutes to administer.


Estimated Enrollment: 65
Study Start Date: May 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulation Group
In the Stimulation group, residents and volunteers will engage in the explicit remediation of memory, reasoning, and selective attention skills using a cognitive stimulation program.
Other: Cognitive stimulation program
The stimulation program is composed of therapy-based exercises which specifically endeavour to maintain the resident's reasoning, memory, and attention skills.
Active Comparator: Control Group
The Control Group residents and volunteers will engage in a "standard" friendly visit during their meeting time.
Other: Standard "Friendly Visit"
Volunteers will provide standard friendly visits to residents which includes a greeting and casual conversation about issues which interest the resident.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 years and over
  • living in a long-term care facility
  • normal or corrected visual and auditory acuity
  • 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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818778

Contacts
Contact: Lorraine van Zon LorraineL22@sympatico.ca

Locations
Canada, Ontario
Baycrest Not yet recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Nicole Anderson, Ph.D.    (416)785-2500 ext 3366    nanderson@research.baycrest.org   
Sub-Investigator: Lorraine van Zon         
Sponsors and Collaborators
Queen's University
Baycrest
Investigators
Principal Investigator: John Kirby, Ph.D. Queen's University
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. John Kirby, Ph.D., Queen's University
ClinicalTrials.gov Identifier: NCT01818778     History of Changes
Other Study ID Numbers: Queens-Baycrest 65
Study First Received: March 19, 2013
Last Updated: March 21, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Learning Disorders
Memory Disorders
Cognition Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on April 17, 2014