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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Tennessee
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Memphis, Tennessee, Forente stater, 38104
- Memphis VA Medical Center, Memphis, TN
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
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Education and skills building, including problem solving, cognitive restructuring, and stress management
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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baseline, 6 months
|
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Burden Measured With the Zarit Burden Inventory
Tidsramme: baseline, 6 months
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Caregiver primary outcome.
Zarit Burden Inventory, 12 item, 0-48, lower better
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baseline, 6 months
|
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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
|
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Number of Patient MS Problems
Tidsramme: baseline, 6 months
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Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
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baseline, 6 months
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Bother With Patient MS Problems
Tidsramme: Baseline, 6 months
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Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
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Baseline, 6 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Linda Olivia Nichols, PhD, Memphis VA Medical Center, Memphis, TN
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E2205-P
- RX002205 (Annen identifikator: Memphis VA Medical Center)
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