Multiple SclerosisNCT02835677
Integrating Caregiver Support Into MS Care
A study testing Behavioral in people with Multiple Sclerosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran being seen in MS clinic at Memphis VA
- Veteran ambulatory
- Caregiver/care partner who agrees to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104
About this study
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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Behavioral
- Keywords
- Caregivers, Activities of Daily Living
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
Education and skills building, including problem solving, cognitive restructuring, and stress management
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation Receives: Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Measured: baseline, 6 months
Burden Measured With the Zarit Burden Inventory
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Measured: baseline, 6 months
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
Measured: baseline, 6 months
Number of Patient MS Problems
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Measured: baseline, 6 months
Bother With Patient MS Problems
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start7 Sep 2016
- Primary completion9 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Memphis VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Linda Olivia Nichols, PhD, Principal investigator, Memphis VA Medical Center, Memphis, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835677
- Sponsor's protocol ID
- E2205-P
- Other IDs
- RX002205
- Status last verified
- May 2019
- First submitted
- 12 Jul 2016
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Caregiver Support Into MS Care
- ClinicalTrials.gov ID
- NCT02835677
- Acronym / sponsor ID
- E2205-P
- Conditions
- Multiple Sclerosis
- Keywords
- Caregivers, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Memphis VA Medical Center
- Study start
- 7 Sep 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: BehavioralBehavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran being seen in MS clinic at Memphis VA
- Veteran ambulatory
- Caregiver/care partner who agrees to participate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BehavioralEducation and skills building, including problem solving, cognitive restructuring, and stress management | Behavioural | Intervention |
Primary outcome
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Time frame: baseline, 6 months
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Burden Measured With the Zarit Burden Inventory
Time frame: baseline, 6 months
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Time frame: baseline, 6 months
Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
Number of Patient MS Problems
Time frame: baseline, 6 months
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Bother With Patient MS Problems
Time frame: Baseline, 6 months
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Olivia Nichols, PhD principal investigator
Memphis VA Medical Center, Memphis, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Multiple Sclerosis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale (time frame: baseline, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.