NCT01818778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

March 19, 2013

Last Update Submit

May 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 weeks

Secondary Outcomes (1)

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

    10 weeks

Other Outcomes (3)

  • Letter Sorting Test

    10 weeks

  • Clock Drawing Test

    10 weeks

  • Action "Verbal Fluency" Test

    10 weeks

Study Arms (2)

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.

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.

Other: Standard Friendly Visit

Interventions

The stimulation program was composed of therapy- and education-based exercises which were specifically designed to stimulate reasoning, memory, and attention skills in adults.

Stimulation Group

Volunteers provided standard "friendly visits" to residents which included a friendly greeting and casual conversation about issues which interest the resident.

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

MeSH Terms

Conditions

Cognition DisordersLearning DisabilitiesMemory Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders

Study Officials

  • John Kirby, Ph.D.

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 26, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations