Memory Intervention for Older Adults - (Social) (Social)

May 9, 2016 updated by: Daniel Saltel, University of Manitoba

Memory Intervention for Older Adults - A Pilot Study

Research shows that there are a plenitude of interventions that can be used to enhance memory for older adults; however, the evidence as to whether these interventions enhance memory for daily activities is equivocal. The purpose of this pilot study is to test a memory intervention that is potentially useful in everyday life. Objectives of the pilot study are: 1) to examine the feasibility of the intervention (e.g., ease of use of materials provided); and 2) to gain preliminary evidence of the intervention's impact on recall of recent daily social events. Participants will be 20 cognitively healthy (i.e. not cognitively impaired) older adults, with 10 participants randomly assigned to either an intervention or control group, respectively. The study will consist of: a) a pre-training session; b) seven days of independent memory training; and c) a post-training session. The pre-training session will involve a test that measures recall of daily social events from the previous week. This will be followed by seven days of training for recall of daily social events. During the seven days, the intervention group will perform daily memory tasks using self-instructional materials given to them by the researcher, whereas the control group will use their own strategies for remembering social events that they are involved in during the week. The post-training session will occur after the seven days and will involve the same test as the pre-training session that measures recall of social events from the previous week. The hypotheses are that: a) recall of social events will be higher for the post-training test than in the pre-training test and; b) recall will be better for in the intervention group than the control group. The ease of use of the memory recall materials provided to the intervention group will be assessed in interviews.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Method Participants The sample will consist of 20 cognitively healthy older adults (aged 55 or older) recruited from the Centre on Aging participant database. The participant database has been approved by the Health REB (REB #HS14652). Individuals who are in the participant database have given their consent to be contacted by researchers about their willingness to participate in specific research projects. Names of individuals are provided to researchers by the Centre on Aging upon submission of REB approval and the research protocol.

Materials Questionnaires Pre-training Questionnaire - demographics. The questionnaire will consist of general questions about the participants. Items will include gender, age, and experience with memory training.

Pre-training memory recall test. The questionnaire will ask participants to describe social events they did during the previous week. This questionnaire will be given in the pre-training session.

Post-training memory recall test. The questionnaire will ask participants to describe social events they did during the previous week. This questionnaire will be given in the post-training session.

Post-training questionnaire. The questionnaire will ask participants about their thoughts regarding the format and usefulness of the instruction materials. For example, participants will be asked if they thought the study helped them remember social events.

Intervention group materials Memory tasks - instructions. This document instructs participants in the intervention group on how to use the memory tasks for daily social events.

Memory tasks - forms. Each day has a separate document that has a) a diary of social events; and b) tasks to review the week's social events.

Memory tasks - forms example. This is an example of the above form filled out to help explain how memory tasks are to be done.

Design This study involves an experimental design, whereby participants will be randomly assigned to one of two groups, an intervention group (n=10) and a control group (n=10). The independent variable is, therefore, the presence or absence of the daily memory recording task for social events. The dependent variables are: (a) the changes in performance on the written recall tests from pre- to post-training; and (b) the difference between the groups (i.e., Control vs. intervention group) on performance of memory of social events. Information about how useful the intervention materials were will be used in a more qualitative way to help improve the intervention.

Procedure The study will consist of: a) a pre-training session; b) seven days of independent memory training (intervention group) or usual way of remembering social events (control group); and c) a post-training session. The pre-training session will involve a test that measures recall of social events from the previous week. This will be followed by seven days of training for recall of daily social events. The post-training session will occur after the seven days and involve the same test as the pre-training session that measures recall of social events from the previous week.

Pre-training session. There will be separate pre-training sessions for each individual participant with the principal investigator either at the University of Manitoba (Bannatyne campus or Fort Garry campus) or, if participants prefers, in his or her own home. During the pre-training session, the principal investigator will provide an informed consent form to the participant. The principal investigator will describe the project, review the consent form and answer any questions. Once the participant provides written consent, a demographics questionnaire will be administered. A pre-training memory recall test will also be done that asks participants to list social events they did during the previous week.

Seven day training week. Materials will be provided to the intervention group during the pre-training session. Materials will include: a) instructions for memory tasks; b) forms for each day for diaries and tasks; and c) an example of the form filled out. The control group will not receive materials and will have to rely on their own memory strategies to remember social events during the 7 days.

Post-training session. There will be separate post-training sessions for each individual participant with the principal investigator either at the University of Manitoba (Bannatyne campus or Fort Garry campus) or in the participants' homes. A post-training memory recall test will be done that asks participants to list social events that they did on the previous week (i.e., this is the same test that was used in pre-training session). The post-training questionnaire will then also be administered to each participants.

Data Management Data will be entered into the computer. The computer file will not contain any names or addresses and each participant data will be identified by a unique participant ID only. Consent forms will be stored in a locked filing cabinet in Dr. Menec's research space (S112 Medical Services Bldg).

Analyses A total score of all social events recalled will be created. Scores will be calculated by the following scheme: a) one point for remembering an event; and b) one point for remembering the day of the event. Other scoring approaches will also be considered; for example, assigning a higher score if more detail about a person met is remembered. SPSS will be used to test hypotheses using two independent group t-tests. The use of t-tests is justified because a) the investigators can compare scoring on pre- and post-session memory recall tests; b) the investigators have an appropriate sample size of 20; and c) the investigators have two independent groups. The usefulness of the memory intervention materials will be examined more qualitatively by looking at responses to each of the questions and participants' comments.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cognitively healthy

Exclusion Criteria:

  • diagnosed cognition impairments such as Alzheimer's

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment

Treatment group will keep diary of social events according to training instructions.

Memory intervention will be used.

keep track of social events in diary for memory recall. Used by treatment group
No Intervention: Control
Control group will use own memory of social events without training instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memory Recall Test (change from first session to second session i.e., 7 days later)
Time Frame: First session, second session (7 days later from first session)
The questionnaire will ask participants to describe social events they did during the previous week.
First session, second session (7 days later from first session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Verena Menec, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 10, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • H2015:243

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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