AzTrials
AzTrials

Memory ImpairmentSocialNCT02499991

Memory Intervention for Older Adults - (Social)

A study testing memory in people with Memory Impairment, run by University of Manitoba.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Memory Impairment
What is being tested?
memory
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Aug 2015to Aug 2017
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • cognitively healthy

Who cannot join

  • diagnosed cognition impairments such as Alzheimer's

About this study

Official title: 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.

Read the 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.

Being tested
memory
Medical subject headings
Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • memoryBehavioural

    keep track of social events in diary for memory recall. Used by treatment group

Study groups in NCT02499991
Study groupRoleWhat they receive
TreatmentExperimentalTreatment group will keep diary of social events according to training instructions. Memory intervention will be used.
Receives: Behavioral: memory
ControlNo interventionControl group will use own memory of social events without training instructions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Memory Recall Test (change from first session to second session i.e., 7 days later)

    The questionnaire will ask participants to describe social events they did during the previous week.

    Measured: First session, second session (7 days later from first session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionAug 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499991
Sponsor's protocol ID
H2015:243
Acronym
Social
Status last verified
May 2016
First submitted
10 Jul 2015
Last updated
10 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing memory in people with Memory Impairment, run by University of Manitoba.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

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)). 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 10 May 2016.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in