- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02281617
Smart-device Apps as Memory Aids
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Purpose and design
This study will trial the use of smartphones and apps as memory aids with patients who have memory problems. There have been some case study reports in the literature but the investigators would like to use this study to investigate how feasible it is to offer these kinds of support within an NHS memory aids service.
Recruitment
Patients (and their relatives/carers, where relevant)will be recruited from those already referred to the Memory Aids Service run within the Neuropsychiatry and Memory Disorders Clinic at St Thomas's Hospital, within the South London and Maudsley NHS Foundation Trust. It is made clear in the Participant Information Sheet (one for patients and one for relatives/carers) that participation is voluntary and if patients do not want to take part, they will still receive personalised help and advice in the Memory Aids Service.
Inclusion/Exclusion
This project will be offered to patients who own their own smartphone; the project is unable to support costs of buying smartphones for patients and paying for any data usage. Patients who do not have smartphones will still receive memory aids support, but instead will receive help as is standardly given using other memory aids.Patients will be excluded if they do not have adequate levels of English or motor skills to use the apps.
Consent
Patients will be identified as possible participants during their routine memory aids assessment clinic visit by a member of the clinical care team. Only those with capacity to consent will be invited to take part. Those interested in taking part will be given a patient information sheet at the end of their assessment appointment (as will their relatives/carers where relevant) and the study will be briefly explained orally. Patients (and their relatives/carers) who do decide to participate will sign the consent form at the beginning of their next Memory Aids appointment and it will be stressed that participation is voluntary and they can withdraw at any time.
Confidentiality
Access to clinical data (pre- and post- intervention memory, mood, functioning, goal and carer stress scores, neuropsychological test scores and interview transcripts) will be restricted to those in the clinical care team until data is fully anonymised. Patients will be asked for consent for their data to be used for the study and a specific point on the informed consent form should be initialled to allow this.
Risks, burdens and benefits
The investigators hope that patients will find benefits in using smartphones as memory aids. The investigators will pay for any apps that are selected to use with them and offer instructions. Use of electronic aids and alarms on phones is well practised within the existing memory aids service. This project adds a semi-structured interview and follow-up phone call and therefore a limited burden for research participants and in some cases their relatives/carers. Since the intervention is non-invasive, the risk to participants is very low.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Subjective memory problems
- Fluent English
- Owns a smartphone or tablet
- sufficient motor skills to operate the smartphone or tablet
- sufficient eyesight to see the smartphone or tablet
Exclusion Criteria:
-
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Vain tapaus
- Aikanäkymät: Tulevaisuuden
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Prospective and Retrospective Memory Questionnaire PRMQ
Aikaikkuna: End of intervention, on average 2 months
|
Subjective memory questionnaire
|
End of intervention, on average 2 months
|
Meta-memory questionnaire MMQ
Aikaikkuna: End of intervention, on average 2 months
|
Questionnaire about beliefs about memory, problems and strategies
|
End of intervention, on average 2 months
|
Hospital Anxiety and Depression Inventory HADS
Aikaikkuna: End of intervention, on average 2 months
|
Questionnaire about anxiety and depression
|
End of intervention, on average 2 months
|
Revised carer stress index
Aikaikkuna: End of intervention, on average 2 months
|
Questionnaire about carer stress
|
End of intervention, on average 2 months
|
Semi-structured interview
Aikaikkuna: End of intervention, on average 2 months
|
Semi-structured interview about usability and usefulness of memory aid apps
|
End of intervention, on average 2 months
|
Brief phone call
Aikaikkuna: 1 year post treatment
|
Brief phone call to ask which apps are still being used
|
1 year post treatment
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: Jennifer Liebscher, MA, South London and Maudsley NHS Foundation Trust
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 139664
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Muistihäiriöt
-
Dart NeuroScience, LLCValmisAge-Associated Memory Impairment (AAMI)Yhdysvallat