- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Stanford, California, Förenta staterna, 94304
- Stanford University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention
Building Better Caregivers Small-group Workshop
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fatigue
Tidsram: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
Pain
Tidsram: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
stress
Tidsram: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
problems sleeping
Tidsram: baseline-1 year
|
visual numeric 0-10 scale
|
baseline-1 year
|
|
depression (PHQ-8)
Tidsram: baseline-1 year
|
8 item 0-3 scale
|
baseline-1 year
|
|
self-efficacy for caregiving
Tidsram: baseline-1 year
|
9-item 1-10 scale
|
baseline-1 year
|
|
caregiver stress
Tidsram: baseline-1 year
|
13-item 3 point scale
|
baseline-1 year
|
|
caregiver burden
Tidsram: baseline-1 year
|
12-item 5 point scale
|
baseline-1 year
|
|
health care utilization (doctor, emergency department, hospital)
Tidsram: baseline-1 year
|
number of times/days in past 6 month visited doctor, emergency department, hospital
|
baseline-1 year
|
|
exercise
Tidsram: baseline- 1 year
|
number of minutes of exercise in past week
|
baseline- 1 year
|
|
general health
Tidsram: baseline-1 year
|
single item scale of overall health
|
baseline-1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
care partner health utilization
Tidsram: baseline- 1 year
|
number of MD ER hospital visits for person being cared for in past 6 months
|
baseline- 1 year
|
|
carepartners general health
Tidsram: baseline-1 year
|
single item scale of overall health of person being cared for
|
baseline-1 year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kate Lorig, DRPH, Stanford School of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 29894
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