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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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.
- 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.
- 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
- 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.
- 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.
- Conditions
- Memory Loss, Age-Related Memory Disorders
- 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
- Presentation of the workshop: Objectives and Methodology
- Explanation of the different types of memory and its implication in normal life
- Strategies for gathering and codification of the information
- Strategies for selection and storage the information
- Strategies for gathering, codification, selection, storage and recuperation of the information. Importance of the context and the meaning of things. Semantic and episodic memory
- Strategies for gathering, codification, selection, storage and recuperation of the information. Individual differences
- Strategies for recuperation according to the individual profile. Improving self-esteem
- Strategies for recuperation Social skills.
- Personal and social skills
- New contexts and opportunities
- Evaluation of the workshop
| Study group | Role | What they receive |
|---|---|---|
| Memory training group | Experimental | Memory 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 group | No intervention | No 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.
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.
- First posted30 Apr 2015 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory LossStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Pérez, MPH, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Evaluate the Effectiveness of Memory Training Workshops in People From 65 to 80 Years
- ClinicalTrials.gov ID
- NCT02431182
- Acronym / sponsor ID
- PI11/02060
- Conditions
- Memory Loss, Age-Related Memory Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory training group | Experimental | Behavioral: Memory Training WorkshopMemory 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. |
| Control group | No intervention | –No intervention will be administred until the delayed post-test is finished |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Having participated in a memory training within the last 3 years
- Having a severe sensorial disability
- Being illiterate/can not read or write
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory Training Workshop1. 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 | Behavioural | Memory training group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Derived from this study: PubMed 26429559Perez 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.
Related trials for Memory Loss
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Pérez, MPH principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
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.