- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00271375
Evaluating the Carter Institute Caregiver Education Program at the VA
22. April 2016 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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 .
Studientyp
Interventionell
Einschreibung (Tatsächlich)
254
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Georgia
-
Decatur, Georgia, Vereinigte Staaten, 30033
- VA Medical Center, Decatur
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
55 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
|
5-week Education and Support Program for Caregivers of older adults.
|
|
Experimental: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Subjective Health
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Patricia Griffiths, PhD, Atlanta VAMC
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2005
Primärer Abschluss (Tatsächlich)
1. August 2009
Studienabschluss (Tatsächlich)
1. Oktober 2009
Studienanmeldedaten
Zuerst eingereicht
29. Dezember 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Dezember 2005
Zuerst gepostet (Schätzen)
30. Dezember 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
30. Mai 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. April 2016
Zuletzt verifiziert
1. April 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- E4044-R
- IRB 2005-050240 (Andere Kennung: Atlanta VAMC)
- IRB 278-2005 (Andere Kennung: Emory University IRB)
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