- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02499991
Memory Intervention for Older Adults - (Social) (Social)
Memory Intervention for Older Adults - A Pilot Study
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- cognitively healthy
Exclusion Criteria:
- diagnosed cognition impairments such as Alzheimer's
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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
|
Brak interwencji: Control
Control group will use own memory of social events without training instructions.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Memory Recall Test (change from first session to second session i.e., 7 days later)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Verena Menec, PhD, University of Manitoba
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- H2015:243
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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