- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02835677
Integrating Caregiver Support Into MS Care
With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of caregiver assistance, with a concomitant increase in burden for the caregiver. In fact, effect on caregiver burden can be seen as a potential indicator of the efficacy of MS management, suggesting that the caregiver is an appropriate and independent target for MS therapeutic strategies.
MS patients report difficulty implementing and continuing with home exercise, mobility, and walking programs. This feasibility study will test integration of a successful behavioral caregiving intervention into clinical practice to improve functioning of Veterans with multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a behavioral caregiver intervention designed to address caregiver coping and management of patient concerns, with special focus on patient mobility and walking. A pre-post intervention design will compare outcomes for Veterans and Caregivers.
For Veterans, the intervention will target Caregiver participation in home-based Veteran mobility activities. MS Caregivers report high burden, stress, and depression involved in caring for their loved ones, especially as mobility declines and these outcomes are related to physical and emotional health status of the patient. For Caregivers, the intervention will focus on improving Caregiver coping and on managing MS-related problems. Outcomes for both will be measured at baseline, 3 months, and 6 months.
Study Objectives include:
- Test whether a caregiver intervention can be integrated into an MS clinical setting.
- Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and number of Veteran MS problems and safety alerts reported).
- Determine whether Veteran outcomes are improved (Expanded Disability Status Scale, timed up and go test, self-efficacy, and depression).
- Determine which types of Caregivers will benefit most.
- Determine which types of Veterans will benefit most.
- Refine materials for future clinical research, translation and implementation.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38104
- Memphis VA Medical Center, Memphis, TN
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Veteran being seen in MS clinic at Memphis VA
- Veteran ambulatory
- Caregiver/care partner who agrees to participate
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
|
Education and skills building, including problem solving, cognitive restructuring, and stress management
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Tidsramme: baseline, 6 months
|
Caregiver primary outcome.
PHQ-9, range 0-27, lower better
|
baseline, 6 months
|
|
Burden Measured With the Zarit Burden Inventory
Tidsramme: baseline, 6 months
|
Caregiver primary outcome.
Zarit Burden Inventory, 12 item, 0-48, lower better
|
baseline, 6 months
|
|
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Tidsramme: baseline, 6 months
|
Caregiver primary outcome.
General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
|
baseline, 6 months
|
|
Number of Patient MS Problems
Tidsramme: baseline, 6 months
|
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
|
baseline, 6 months
|
|
Bother With Patient MS Problems
Tidsramme: Baseline, 6 months
|
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
|
Baseline, 6 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Linda Olivia Nichols, PhD, Memphis VA Medical Center, Memphis, TN
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E2205-P
- RX002205 (Anden identifikator: Memphis VA Medical Center)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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