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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- Memphis VA Medical Center, Memphis, TN
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Veteran being seen in MS clinic at Memphis VA
- Veteran ambulatory
- Caregiver/care partner who agrees to participate
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Tidsram: baseline, 6 months
|
Caregiver primary outcome.
PHQ-9, range 0-27, lower better
|
baseline, 6 months
|
|
Burden Measured With the Zarit Burden Inventory
Tidsram: 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
Tidsram: 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
Tidsram: baseline, 6 months
|
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
|
baseline, 6 months
|
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Bother With Patient MS Problems
Tidsram: Baseline, 6 months
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Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
|
Baseline, 6 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Linda Olivia Nichols, PhD, Memphis VA Medical Center, Memphis, TN
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E2205-P
- RX002205 (Annan identifierare: Memphis VA Medical Center)
Plan för individuella deltagardata (IPD)
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