- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00271375
Evaluating the Carter Institute Caregiver Education Program at the VA
22 kwietnia 2016 zaktualizowane przez: VA Office of Research and Development
This project implemented and evaluated the Rosalyn Carter Institute's (RCI's) educational and support program for caregivers, "Caring for You, Caring for Me." Specifically, it examined effects of the program upon family caregivers to older adults in the Atlanta area and elderly Veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center (VAMC).
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Primary objectives of the research were:
- to evaluate user satisfaction with and perceived utility of the "Caring for You, Caring for Me" caregiver educational program among formal (VHA staff) and informal (family) caregivers who undergo the program;
- to assess effects of the program upon psychosocial and physical well-being of informal caregivers over a 1-year period .
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
254
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Georgia
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Decatur, Georgia, Stany Zjednoczone, 30033
- VA Medical Center, Decatur
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
55 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Family members of Veterans aged 65+ years and receiving care through the Atlanta VAMC's Clinic and Atlanta area.
- Must be the primary caregiver to someone 55 and over.
- Must have been assisting with at least one activity of daily living (ADL) for at least 6 months prior to beginning the intervention.
Exclusion Criteria:
- Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nielosowe
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
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5-week Education and Support Program for Caregivers of older adults.
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Eksperymentalny: Arm 2: Caring for you, caring for me + social worker
Educational + Social Work Intervention
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5-week Education and Support Program for Caregivers of older adults.+
augmentation with social worker
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Komparator placebo: Arm 3: Control group usual care
Control group usual care
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Control group usual care
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
To Evaluate User Satisfaction With and Perceived Utility of the "Caring for You, Caring for Me" Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program
Ramy czasowe: 18 Months
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This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.
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18 Months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Subjective Health
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago.
Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical Role Function
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver.
4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical Function
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities).
10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Depressive Symptoms
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form).
The CES-D is a 10 Question Scale with total scores ranging from 0-30.
Mean scores were calculated by finding the total sum divided by the total number of participants.
Any score equal to or above 10 is considered depressed.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Burden
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always).
Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Satisfaction
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot).
Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Mastery
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot).
Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Efficacy
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Personal Mastery
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Perceived Social Support
Ramy czasowe: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Patricia Griffiths, PhD, Atlanta VAMC
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2005
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2009
Ukończenie studiów (Rzeczywisty)
1 października 2009
Daty rejestracji na studia
Pierwszy przesłany
29 grudnia 2005
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 grudnia 2005
Pierwszy wysłany (Oszacować)
30 grudnia 2005
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
30 maja 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 kwietnia 2016
Ostatnia weryfikacja
1 kwietnia 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- E4044-R
- IRB 2005-050240 (Inny identyfikator: Atlanta VAMC)
- IRB 278-2005 (Inny identyfikator: Emory University IRB)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Caring For You, Caring For Me
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