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

Primary Purpose

Impaired Cognition, Geriatric Disorder, Learning Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive stimulation program
Standard Friendly Visit
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impaired Cognition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baycrest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimulation Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Test of Memory and Learning - Senior Edition (TOMAL-SE)
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.

Secondary Outcome Measures

Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II; Wechsler, 2011)
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.

Full Information

First Posted
March 19, 2013
Last Updated
May 15, 2014
Sponsor
Queen's University
Collaborators
Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT01818778
Brief Title
The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes
Acronym
VolCogStim
Official Title
The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Baycrest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many volunteers visiting seniors make socially-based "friendly visits". This study investigated the efficacy of volunteers making visits focused on stimulating cognition. Participants were randomly assigned to either a "friendly visit" control group or a cognitive stimulation group. Seniors receiving stimulation visits made statistically significant improvement in memory abilities.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Cognition, Geriatric Disorder, Learning Disorders, Age-Related Memory Disorders, Impairment of Attention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive stimulation program
Intervention Description
The stimulation program was composed of therapy- and education-based exercises which were specifically designed to stimulate reasoning, memory, and attention skills in adults.
Intervention Type
Other
Intervention Name(s)
Standard Friendly Visit
Intervention Description
Volunteers provided standard "friendly visits" to residents which included a friendly greeting and casual conversation about issues which interest the resident.
Primary Outcome Measure Information:
Title
Test of Memory and Learning - Senior Edition (TOMAL-SE)
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II; Wechsler, 2011)
Description
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.
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Letter Sorting Test
Description
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.
Time Frame
10 weeks
Title
Clock Drawing Test
Description
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.
Time Frame
10 weeks
Title
Action "Verbal Fluency" Test
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kirby, Ph.D.
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada

12. IPD Sharing Statement

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The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes

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