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Memory LossNCT02431182

Trial to Evaluate the Effectiveness of Memory Training Workshops in People From 65 to 80 Years

A study testing Memory Training Workshop in people with Memory Loss and Age-Related Memory Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized controlled trial to assess the effectiveness of a Memory Training Workshop in cognitive function, in terms of self-perceived memory, everyday memory and executive control abilities. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Memory Loss, Age-Related Memory Disorders
What is being tested?
Memory Training Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSpain
Study dates
Jan 2012to Jun 2014
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • People of both sexes between 65 and 80 years old (including these ages) who consent to participate in the study.
  • Not presenting diagnoses of dementia or cognitive impairment measured through the Mini-Mental State Examination (MMSE >24)
  • Absence of depression measured by the Geriatric Depression Scale (GDS 5 ≤ 2)

Who cannot join

  • Having participated in a memory training within the last 3 years
  • Having a severe sensorial disability
  • Being illiterate/can not read or write

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Agència de Salut Pública de Barcelona

    Barcelona, Barcelona, 08023

Other trials in Spain

About this study

Official title: Randomized Control Trial to Evaluate the Effectiveness of Memory Training Workshops in People From 65 to 80 Years

Randomized controlled trial to assess the effectiveness of a Memory Training Workshop in cognitive function, in terms of self-perceived memory, everyday memory and executive control abilities. It is expected that the group intervention of memory training that this study proposes significantly improves cognition (memory, attention and executive control abilities) and the quality of life related to health (HRQOL) in the Experimental Group (EG) compared to the Control Group (CG). The group of individuals that take part in the Memory Training Workshops (Experimental Group) will be compared to another group of similar characteristics that do not (Control Group). Data will be collected at baseline, 3 months later and 6 months later.

Read the detailed description

Study design: Randomized controlled trial, comparing one group of individuals that take part in the Memory Training Workshops (Experimental Group) with another group of similar characteristics that do not (Control Group). Data will be collected at baseline, 3 months later and 6 months later.

Setting: The study will be done in Health Care Centres of Barcelona City (Spain) Randomization unit: Individuals Study Population: Healthy older people belonging to the four Health Care Centres included in the study and that meet the inclusion criteria

Description of the study procedure:

  1. Recruitment and screening: Recruitment will be conducted in the four participating Health Care Centres through printed materials.(leaflets and posters) in the Health Care Centres and close community sites (library, pharmacy, market or elderly meeting centre). Interested individuals will have to contact their corresponding Health Care Centre where they will be first screened regarding age (older than 65 and younger than 81) and previous memory training (not having been involved in memory training during the 3 previous years). Those who meet both criteria will be cited for a inclusion interview with a study-trained doctor or nurse at the Health Care Centre.
  2. Inclusion and randomisation: Informed consent follows the requirements of the institution's Ethics Comitee. Written consent to participate will be obtained in-person assessment at the beginning of the screening interview. Selection of the participants will be performed through the screening interview, where data will be sought for regarding socio-demographic questions, the Short version of the Geriatric Depression Scale (GDS-5), the Mini Mental State Examination (MMSE) and the medical history with the active clinical diagnoses and active medication. After the screening interview and if the participant is eligible and willing, the individual will be randomly assigned to the EG or to the CG through a closed and opaque envelope with the group information inside. Total time required for screening is around 30 minutes.
  3. Baseline and follow-up assessments: Three assessments will be conducted through the study: at baseline after randomisation, post-intervention at time-point between 3 and 4 months post-baseline (immediate post-test), follow-up at time-point 6 months post-baseline (delayed post-test). All three assessments will collect information on variables detailed in Table 1, and will be conducted by a trained psychologist trough in-person interviews in the Health Care Centre. Time requirements will be around 75 minutes for the baseline assessment, and around 90 minutes for the follow-up assessments
  4. Implementation of the intervention by the experimental group: Once the baseline assessment is conducted, the individuals of the EG will start the multifactorial intervention. The memory training workshop is designed to stop or delay memory losses age-related and to promote personal autonomy enhancing mental and physical wellbeing. Concretely, it pretends to wider the knowledge about memory function, to improve memory process and to increase self-esteem and the quality of life by giving some strategies and some relational space. The intervention consists of twelve 90-minutes group sessions given once a week by a specialized psychologist. The groups are formed by around 15 people. Each session has its own objectives, material and activities. The content of the intervention is based on memory training from different perspectives as cognitive and emotional aspects or social and individual skills.
  5. Standardization of Assessment: Standardization of data collection procedures will be ensured through a variety of training and quality-control procedures. Data collectors will be masked with regard to treatment group assignment. All data collectors will participate in an intensive 2-day training workshop which includes information about the study design, recruitment issues, and general research interviewing principles; detailed instruction in the administration of each test or measurement procedure; demonstrations of each test/measurement; and practice sessions with other data collectors. Furthermore, they will use an easy and friendly answer sheet specially designed for the study. Fulfilled sheets will be always reviewed by the fieldwork coordinator, who in case of missing data or possible mistakes will contact with data collectors to solve any doubt.
Being tested
Memory Training Workshop
Medical subject headings
Memory Disorders

What participants receive

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

  • Memory Training WorkshopBehavioural

    1. Presentation of the workshop: Objectives and Methodology
    2. Explanation of the different types of memory and its implication in normal life
    3. Strategies for gathering and codification of the information
    4. Strategies for selection and storage the information
    5. Strategies for gathering, codification, selection, storage and recuperation of the information. Importance of the context and the meaning of things. Semantic and episodic memory
    6. Strategies for gathering, codification, selection, storage and recuperation of the information. Individual differences
    7. Strategies for recuperation according to the individual profile. Improving self-esteem
    8. Strategies for recuperation Social skills.
    9. Personal and social skills
    10. New contexts and opportunities
    11. Evaluation of the workshop
Study groups in NCT02431182
Study groupRoleWhat they receive
Memory training groupExperimentalMemory training:The intervention consists of twelve 90-minutes group sessions given once a week by a specialized psychologist. The groups are formed by around 15 people. Each session has its own objectives, material and activities. The content of the intervention is based on memory training from different perspectives as cognitive and emotional aspects or social and individual skills.
Receives: Behavioral: Memory Training Workshop
Control groupNo interventionNo intervention will be administred until the delayed post-test is finished

What is being measured

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

  1. Change from baseline in Everyday Memory at 3 and 6 months measured by the Rivermead Behavioural Memory test

    Measured: baseline, at 3 months from baseline and at 6 months from baseline

Timeline

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

  1. First posted30 Apr 2015 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2014
  4. Study completionJun 2014

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02431182
Sponsor's protocol ID
PI11/02060
Status last verified
Dec 2014
First submitted
22 Apr 2015
Last updated
30 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Perez A, Roque M, Domenech S, Monteserin R, Soriano N, Blancafort X, Bosom M, Vidal C, Petit M, Hortal N, Gil C, Espelt A, Lopez MJ. Efficacy of memory training in healthy community-dwelling older people: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Oct 1;15:113. doi: 10.1186/s12877-015-0110-4.

    PubMed 26429559

Questions about this trial

What is this clinical trial studying?

A study testing Memory Training Workshop in people with Memory Loss and Age-Related Memory Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 3 inclusion and 3 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 30 Apr 2015. 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 Spain. 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?

Change from baseline in Everyday Memory at 3 and 6 months measured by the Rivermead Behavioural Memory test (time frame: baseline, at 3 months from baseline and at 6 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02431182, which also lists 1 linked publication.

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 30 Apr 2015.

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