Impaired CognitionVolCogStimNCT01818778
The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes
A study testing Cognitive stimulation program and Standard Friendly Visit in people with Impaired Cognition and Geriatric Disorder, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impaired Cognition, Geriatric Disorder, Learning Disorders
- What is being tested?
- Cognitive stimulation program and Standard Friendly Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Impaired Cognition, Geriatric Disorder, Learning Disorders, Age-Related Memory Disorders, Impairment of Attention
- Being tested
- Cognitive stimulation program, Standard Friendly Visit
- Medical subject headings
- Cognition Disorders, Learning Disabilities, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulation programOther
The stimulation program was composed of therapy- and education-based exercises which were specifically designed to stimulate reasoning, memory, and attention skills in adults.
Standard Friendly VisitOther
Volunteers provided standard "friendly visits" to residents which included a friendly greeting and casual conversation about issues which interest the resident.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Group | Experimental | 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. Receives: Other: Cognitive stimulation program |
| Control Group | Active comparator | 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. Receives: Other: Standard Friendly Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (1)
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Baycrest
- Responsible party
- Principal investigator, Dr. John Kirby, Queen's University
- Investigators
- John Kirby, Ph.D., Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818778
- Sponsor's protocol ID
- Queens-Baycrest 65
- Acronym
- VolCogStim
- Status last verified
- May 2014
- First submitted
- 19 Mar 2013
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Using Volunteers to Implement a Cognitive Stimulation Program in Two Long-Term Care Homes
- ClinicalTrials.gov ID
- NCT01818778
- Acronym / sponsor ID
- VolCogStim / Queens-Baycrest 65
- Conditions
- Impaired Cognition, Geriatric Disorder, Learning Disorders, Age-Related Memory Disorders, Impairment of Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Baycrest
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation Group | Experimental | Other: Cognitive stimulation programCognitive 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. |
| Control Group | Active comparator | Other: Standard Friendly VisitStandard "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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive stimulation programThe stimulation program was composed of therapy- and education-based exercises which were specifically designed to stimulate reasoning, memory, and attention skills in adults. | Other | Stimulation Group |
| Standard Friendly VisitVolunteers provided standard "friendly visits" to residents which included a friendly greeting and casual conversation about issues which interest the resident. | Other | Control Group |
Primary outcome
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.
1 secondary outcome
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II; Wechsler, 2011)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kirby, Ph.D. principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation program and Standard Friendly Visit in people with Impaired Cognition and Geriatric Disorder, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Memory and Learning - Senior Edition (TOMAL-SE) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.