- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00271375
Evaluating the Carter Institute Caregiver Education Program at the VA
22 april 2016 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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 .
Studietyp
Interventionell
Inskrivning (Faktisk)
254
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Georgia
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Decatur, Georgia, Förenta staterna, 30033
- VA Medical Center, Decatur
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
55 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
|
5-week Education and Support Program for Caregivers of older adults.
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Experimentell: 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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Placebo-jämförare: Arm 3: Control group usual care
Control group usual care
|
Control group usual care
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: 18 Months
|
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.
|
18 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Subjective Health
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
|
Physical Role Function
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
Caregiver Satisfaction
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
Caregiver Mastery
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
Caregiver Efficacy
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
|
Personal Mastery
Tidsram: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
Tidsram: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Patricia Griffiths, PhD, Atlanta VAMC
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2005
Primärt slutförande (Faktisk)
1 augusti 2009
Avslutad studie (Faktisk)
1 oktober 2009
Studieregistreringsdatum
Först inskickad
29 december 2005
Först inskickad som uppfyllde QC-kriterierna
29 december 2005
Första postat (Uppskatta)
30 december 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 april 2016
Senast verifierad
1 april 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- E4044-R
- IRB 2005-050240 (Annan identifierare: Atlanta VAMC)
- IRB 278-2005 (Annan identifierare: Emory University IRB)
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