- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00271375
Evaluating the Carter Institute Caregiver Education Program at the VA
22. april 2016 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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 .
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
254
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Georgia
-
Decatur, Georgia, Forenede Stater, 30033
- VA Medical Center, Decatur
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
|
5-week Education and Support Program for Caregivers of older adults.
|
|
Eksperimentel: Arm 2: Caring for you, caring for me + social worker
Educational + Social Work Intervention
|
5-week Education and Support Program for Caregivers of older adults.+
augmentation with social worker
|
|
Placebo komparator: Arm 3: Control group usual care
Control group usual care
|
Control group usual care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Health
Tidsramme: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
|
Physical Role Function
Tidsramme: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
|
Physical Function
Tidsramme: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
|
Depressive Symptoms
Tidsramme: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
|
Caregiver Burden
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
|
Personal Mastery
Tidsramme: 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).
|
Baseline, 6 Month Follow-up, 12 Month Follow-up
|
|
Perceived Social Support
Tidsramme: Baseline, 6 Month Follow-up, 12 Month Follow-up
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Patricia Griffiths, PhD, Atlanta VAMC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2005
Primær færdiggørelse (Faktiske)
1. august 2009
Studieafslutning (Faktiske)
1. oktober 2009
Datoer for studieregistrering
Først indsendt
29. december 2005
Først indsendt, der opfyldte QC-kriterier
29. december 2005
Først opslået (Skøn)
30. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- E4044-R
- IRB 2005-050240 (Anden identifikator: Atlanta VAMC)
- IRB 278-2005 (Anden identifikator: Emory University IRB)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .