- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02205671
Building Better Caregivers: Development and Evaluation
The program consists of a 6-week small-group workshop for caregivers of people with memory problems.
The goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and self-efficacy
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a 2-day cross-training before leading a BBC workshop).
Participants will learn self-management skills such as decision making, goal setting, action planning, stress management, dealing with difficult behaviors, working with the health care system, planning for the future,building an exercise program, communication skills, healthy eating, etc.
All participants will complete follow up questionnaires and 6 and 12 months. They will have the option of completing the questionnaire by mail or telephone interview.
Once a particular workshop site is identified by a partner organization, Stanford will provide packets of consents and questionnaires to the site coordinator(non-Stanford). The site coordinator will either schedule an extra hour for the first meeting of the 6-week series, or an orientation meeting held a week or so before the workshop begins. During this time, the coordinator will announce to the prospective subjects that this study is being conducted and that they are invited to participate, and will pass out a consent, questionnaire and consent copy to each prospective participant. The consent and questionnaire are self-administered.
This study is longitudinal, so no randomization will take place.
Stanford holds no meetings, but receives the data. The site coordinators hold the orientation meetings. The workshops are scheduled by the various organizations, and they determine when and how the orientation time is scheduled. It will vary from site to site.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Stanford, California, Forente stater, 94304
- Stanford University School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Family or friend caregiver of someone with cognitive impairment for at least 10 hours per week
- 18 years of age or older
- Able to attend a workshop 2.5 hours per week for 6 weeks
- Speaks English
Exclusion Criteria:
- Professional caregiver
- Under 18 years of age
- Non-English speaking
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
Building Better Caregivers Small-group Workshop
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fatigue
Tidsramme: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
Pain
Tidsramme: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
stress
Tidsramme: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
problems sleeping
Tidsramme: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
depression (PHQ-8)
Tidsramme: baseline-1 year
|
8 item 0-3 scale
|
baseline-1 year
|
|
self-efficacy for caregiving
Tidsramme: baseline-1 year
|
9-item 1-10 scale
|
baseline-1 year
|
|
caregiver stress
Tidsramme: baseline-1 year
|
13-item 3 point scale
|
baseline-1 year
|
|
caregiver burden
Tidsramme: baseline-1 year
|
12-item 5 point scale
|
baseline-1 year
|
|
health care utilization (doctor, emergency department, hospital)
Tidsramme: baseline-1 year
|
number of times/days in past 6 month visited doctor, emergency department, hospital
|
baseline-1 year
|
|
exercise
Tidsramme: baseline- 1 year
|
number of minutes of exercise in past week
|
baseline- 1 year
|
|
general health
Tidsramme: baseline-1 year
|
single item scale of overall health
|
baseline-1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
care partner health utilization
Tidsramme: baseline- 1 year
|
number of MD ER hospital visits for person being cared for in past 6 months
|
baseline- 1 year
|
|
carepartners general health
Tidsramme: baseline-1 year
|
single item scale of overall health of person being cared for
|
baseline-1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kate Lorig, DRPH, Stanford School of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 29894
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