Examining the Effect of a Simple Memory Tool

NCT03244111 | Unknown

• 1 other identifier: H2017:105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: There have been a wide variety of interventions to assist with cognition and memory of older adults; however, it is often unclear if the interventions have an impact on daily life memory performance and goal attainment. The objectives of this study are to examine: 1) whether an intervention that involves a simple memory tool assists with daily life memory performance and goal attainment of older adults; and 2) whether the intervention has a different effect for individuals with healthy cognition versus individuals with mild cognitive impairment (MCI). Research Questions: Can a simple memory tool assist with daily life memory performance and goal attainment for older adults? Does the simple memory tool have a different effect for individuals with healthy cognition and individuals with MCI? Methods: The study will use a mixed 2 X 3 design with cognition (healthy, MCI) as the between subjects factor and time (session 1, 2, 3) as the within-subjects factor. There will be 40 older adults who have healthy cognition and 20 older adults who have MCI. The study will consist of 3 sessions for each participant. The sessions will be held once a week and incorporate: a) the Montreal Cognitive Assessment (MOCA) to determine level of cognition (healthy, MCI); b) the Prospective and Retrospective Memory Questionnaire (PRMQ) to help determine daily memory performance; c) a memory recall test for recent daily events to help determine daily memory performance; d) the goals of the participants using the Goal Attainment Scaling (GAS); and e) the development of checklists that are tailored to address goals. In between the sessions, participants will perform the checklists and update the diary with notes of what they want to remember on a daily basis. The hypotheses are that: 1) memory performance (i.e., measured with memory recall of daily events and PRMQ), and goal attainment will increase from session to session; 2) participants with healthy cognition will have better memory performance and goal attainment than participants with MCI; and 3) participants with healthy cognition will have greater gains in memory performance and goal attainment than participants with MCI.

Conditions

Memory Impairment

Outcome Measures

Primary Outcomes (3)

• Goal Attainment Scaling (GAS) - Change from baseline to session 2 and 3

  The GAS is a method for measuring goal attainment. It relies on self-report questions that ask if participants met their goals.

  GAS is assessed during session 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.

• Memory Recall Test - Change from sessions 1, 2 and 3

  Participants are asked to recall events that occurred last week (i.e., between sessions with the researcher)

  Memory recall is assessed during session 1, 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.

• Prospective and Retrospective Memory Questionnaire (PRMQ) - Change from session 1 to 3

  PRMQ is a questionnaire about daily memory difficulties

  PRMQ is assessed during session 1 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.

Study Arms (2)

Healthy Cognition

ACTIVE COMPARATOR

The intervention will be carried out as described in the study details using the simple memory tool. The group with healthy cognition may perform better on tasks since they have a higher level of cognition.

Behavioral: simple memory tool

MCI

ACTIVE COMPARATOR

The intervention will be carried out as described in the study details using the simple memory tool. The group with MCI may have a lower level of performance on tasks since they have a lower level of cognition. Some tasks may take longer for the participant or need more explanation from the researcher (e.g., explanation of a question).

Behavioral: simple memory tool

Interventions

simple memory tool BEHAVIORAL

The goals may be implemented using the simple memory tool. Simple memory tool involves using materials such as checklists or diaries to assist with memory.

Healthy Cognition; MCI

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy cognition
• high level of cognition as determined by MOCA scores
• lower level of cognition as determined by MOCA scores
• such as mild cognitive impairment (MCI)

You may not qualify if:

• If there is impairment that does not allow participants to perform intervention tasks on their own, then assistance may occur by a caregiver. As long as the participant is willing to be involved they can participate in the study. If participants are having too much difficulty they may wish to withdraw from study.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Verena Menec, PhD

  University of Manitoba

  STUDY DIRECTOR

Central Study Contacts

Daniel Saltel

CONTACT

204-257-7145; umsalt23@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Community Health Science Msc Student

Model Details: The MOCA is a one page test that assesses cognition. The MOCA will be administered and participants with total scores \<= 25 will be in the lower cognition group, whereas participants with total scores \> 25 will be in the higher cognition group. These are recommended cut off scores to detect mild cognitive impairment (MCI).

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 9, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

CA (1)