Multiple SclerosisNCT01302431
Nurse-Led Manualized Telephone Support Intervention
A study testing Manualised nurse-led telephone support in people with Multiple Sclerosis, run by University of Dublin, Trinity College at 2 sites in Ireland.
Trial summary
The primary aim of this study is to determine if a manual based telephone intervention support service for people who support people with Multiple Sclerosis (PwMS), initiated by nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and their support persons. 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?
- Manualised nurse-led telephone support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesIreland
- Study dates
- Apr 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- PwMS:
- People who have a diagnosis of Multiple Sclerosis and are > 18 years of age.
- PwMS who nominate a caregiver.
- Caregivers:
- Informal caregivers of PwMS who do not have a serious mental health problem.
- Nurses: Nurse Specialists caring for PwMS and who agree to take part in the study.
Who cannot join
- For PwMS:
- PwMS who cannot nominate a caregiver
- PwMS who are already engaged in similar research
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Exploratory Randomized Controlled Trial of a Manualized, Nurse-led, Telephone Intervention Support Service for Support Persons of People With Multiple Sclerosis
The primary aim of this study is to determine if a manual based telephone intervention support service for people who support people with Multiple Sclerosis (PwMS), initiated by nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and their support persons. For support persons this impact is determined by measurable support person/carer self-efficacy and preparedness to care, burden, quality of life, service utilization and satisfaction with the support service. For PwMS this is determined by their qualitative experience of the type of care they receive from their carer. A secondary aim is to determine the possible economic benefits of the introduction of such an intervention nationally. A support person is the person nominated by the PwMS as the person who provides the most support or physical assistance to a person with MS who is not a paid service provider.
Read the detailed description
The negative impact of caregiving on caregivers of People with Multiple Sclerosis (PwMS) has been well documented (Corry \& While, 2008). Outside of scheduled health care contacts, caregivers usually make contact with nurse specialists when in distress or in crisis situations. Nurses specialising in MS have specialised knowledge in caring for PwMS and their caregivers and the management of symptoms of MS, and are well positioned to provide specialist advice, information and referral. Much of the unique support given to caregivers of PwMS by MS nurses in Ireland is undocumented so that their impact upon patient and carer outcomes is unknown.
The well-being of caregivers of PwMS is crucial with limited budgets resulting in increased reliance upon caregivers to provide ongoing support for PwMS. Health care professionals need to prioritise health promotion, information giving and pro-active management of situations among caregivers of PwMS if the deleterious effects of care-giving on the PwMS and their caregivers are to be minimised and poor health avoided.
A search of the literature revealed that no published studies exist on the use of telephone support interventions for caregivers of PwMS. The extent to which telephone support interventions have been used in an attempt to support caregivers is evident from the number of studies found on carer telephone support across a number of illnesses (n=29). The range of care recipients, research designs and objectives for the studies make it difficult to draw definitive conclusions regarding particular outcomes and interventions. However, positive findings include feeling supported (Bank et al. 2006, Stewart et al. 2001), feeling empowered (Wilkes et al. 2004; Stewart et al. 2001) and reduced carer burden (Bormann et al. 2009; Tremont et al. 2008; Stewart et al. 2001).
The positive findings from the studies on telephone support interventions, along with the current use of carer telephone contact with NSMS when in crisis, suggest that a nurse specialist proactive approach to problem management, information and advice giving has potential for positive outcomes for caregivers of PwMS.
For the purpose of this study a carer is defined as a person who provides the most support or physical assistance to a PwMS, and who is not a paid service provider.
- Conditions
- Multiple Sclerosis
- Being tested
- Manualised nurse-led telephone support
- Keywords
- experimental, intervention, nurse-led, nurse specialist, multiple sclerosis, support of caregivers
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manualised nurse-led telephone supportOther
The manualised nurse-led telephone support intervention is designed to provide proactive support and enable caregivers of people with multiple sclerosis manage problems encountered with caregiving
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Manualised Telephone support | Experimental | Participants assigned to this arm of the study will receive 4 nurse-led telephone support calls over a three month time-frame Receives: Other: Manualised nurse-led telephone support |
| Usual care | No intervention | Participants randomised to this arm of the study will receive their usual care which comprises caregivers calling nurse specialists when they needs advice and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Support person/caregiver Self-efficacy
This outcome measures support person/caregiver self-efficacy for obtaining respite and self-efficacy in problem solving
Measured: 3 months
Secondary outcomes (1)
Support person/caregiver preparedness to care
This outcome measure measures how well support persons/caregivers feel prepared to care for a PwMS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Corry, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302431
- Sponsor's protocol ID
- NLTSI
- Status last verified
- Dec 2014
- First submitted
- 23 Feb 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.
PubMed 20228893Stewart MJ, Hart G, Mann K, Jackson S, Langille L, Reidy M. Telephone support group intervention for persons with hemophilia and HIV/AIDS and family caregivers. Int J Nurs Stud. 2001 Apr;38(2):209-25. doi: 10.1016/s0020-7489(00)00035-3.
PubMed 11223062Bormann J, Warren KA, Regalbuto L, Glaser D, Kelly A, Schnack J, Hinton L. A spiritually based caregiver intervention with telephone delivery for family caregivers of veterans with dementia. Fam Community Health. 2009 Oct-Dec;32(4):345-53. doi: 10.1097/FCH.0b013e3181b91fd6.
PubMed 19752637Bank AL, Arguelles S, Rubert M, Eisdorfer C, Czaja SJ. The value of telephone support groups among ethnically diverse caregivers of persons with dementia. Gerontologist. 2006 Feb;46(1):134-8. doi: 10.1093/geront/46.1.134.
PubMed 16452294Corry M, While A. The needs of carers of people with multiple sclerosis: a literature review. Scand J Caring Sci. 2009 Sep;23(3):569-88. doi: 10.1111/j.1471-6712.2008.00645.x. Epub 2008 Dec 9.
PubMed 19077062
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Controlled Trial of a Manualized, Nurse-led, Telephone Intervention Support Service for Support Persons of People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01302431
- Acronym / sponsor ID
- NLTSI
- Conditions
- Multiple Sclerosis
- Keywords
- experimental, intervention, nurse-led, nurse specialist, multiple sclerosis, support of caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to determine if a manual based telephone intervention support service for people who support people with Multiple Sclerosis (PwMS), initiated by nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and their support persons. For support persons this impact is determined by measurable support person/carer self-efficacy and preparedness to care, burden, quality of life, service utilization and satisfaction with the support service. For PwMS this is determined by their qualitative experience of the type of care they receive from their carer. A secondary aim is to determine the possible economic benefits of the introduction of such an intervention nationally. A support person is the person nominated by the PwMS as the person who provides the most support or physical assistance to a person with MS who is not a paid service provider.
Detailed description
The negative impact of caregiving on caregivers of People with Multiple Sclerosis (PwMS) has been well documented (Corry \& While, 2008). Outside of scheduled health care contacts, caregivers usually make contact with nurse specialists when in distress or in crisis situations. Nurses specialising in MS have specialised knowledge in caring for PwMS and their caregivers and the management of symptoms of MS, and are well positioned to provide specialist advice, information and referral. Much of the unique support given to caregivers of PwMS by MS nurses in Ireland is undocumented so that their impact upon patient and carer outcomes is unknown.
The well-being of caregivers of PwMS is crucial with limited budgets resulting in increased reliance upon caregivers to provide ongoing support for PwMS. Health care professionals need to prioritise health promotion, information giving and pro-active management of situations among caregivers of PwMS if the deleterious effects of care-giving on the PwMS and their caregivers are to be minimised and poor health avoided.
A search of the literature revealed that no published studies exist on the use of telephone support interventions for caregivers of PwMS. The extent to which telephone support interventions have been used in an attempt to support caregivers is evident from the number of studies found on carer telephone support across a number of illnesses (n=29). The range of care recipients, research designs and objectives for the studies make it difficult to draw definitive conclusions regarding particular outcomes and interventions. However, positive findings include feeling supported (Bank et al. 2006, Stewart et al. 2001), feeling empowered (Wilkes et al. 2004; Stewart et al. 2001) and reduced carer burden (Bormann et al. 2009; Tremont et al. 2008; Stewart et al. 2001).
The positive findings from the studies on telephone support interventions, along with the current use of carer telephone contact with NSMS when in crisis, suggest that a nurse specialist proactive approach to problem management, information and advice giving has potential for positive outcomes for caregivers of PwMS.
For the purpose of this study a carer is defined as a person who provides the most support or physical assistance to a PwMS, and who is not a paid service provider.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Manualised Telephone support | Experimental | Other: Manualised nurse-led telephone supportParticipants assigned to this arm of the study will receive 4 nurse-led telephone support calls over a three month time-frame |
| Usual care | No intervention | –Participants randomised to this arm of the study will receive their usual care which comprises caregivers calling nurse specialists when they needs advice and support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People who have a diagnosis of Multiple Sclerosis and are > 18 years of age.
- PwMS who nominate a caregiver.
- Informal caregivers of PwMS who do not have a serious mental health problem.
- Nurses: Nurse Specialists caring for PwMS and who agree to take part in the study.
Key exclusion criteria (3 listed)
- PwMS who cannot nominate a caregiver
- PwMS who are already engaged in similar research
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 |
|---|---|---|
| Manualised nurse-led telephone supportThe manualised nurse-led telephone support intervention is designed to provide proactive support and enable caregivers of people with multiple sclerosis manage problems encountered with caregiving | Other | Nurse-Led Manualised Telephone support |
Primary outcome
Support person/caregiver Self-efficacy
Time frame: 3 months
This outcome measures support person/caregiver self-efficacy for obtaining respite and self-efficacy in problem solving
1 secondary outcome
Support person/caregiver preparedness to care
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 20228893Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.
- Background: PubMed 11223062Stewart MJ, Hart G, Mann K, Jackson S, Langille L, Reidy M. Telephone support group intervention for persons with hemophilia and HIV/AIDS and family caregivers. Int J Nurs Stud. 2001 Apr;38(2):209-25. doi: 10.1016/s0020-7489(00)00035-3.
- Background: PubMed 19752637Bormann J, Warren KA, Regalbuto L, Glaser D, Kelly A, Schnack J, Hinton L. A spiritually based caregiver intervention with telephone delivery for family caregivers of veterans with dementia. Fam Community Health. 2009 Oct-Dec;32(4):345-53. doi: 10.1097/FCH.0b013e3181b91fd6.
- Background: PubMed 16452294Bank AL, Arguelles S, Rubert M, Eisdorfer C, Czaja SJ. The value of telephone support groups among ethnically diverse caregivers of persons with dementia. Gerontologist. 2006 Feb;46(1):134-8. doi: 10.1093/geront/46.1.134.
- Background: PubMed 19077062Corry M, While A. The needs of carers of people with multiple sclerosis: a literature review. Scand J Caring Sci. 2009 Sep;23(3):569-88. doi: 10.1111/j.1471-6712.2008.00645.x. Epub 2008 Dec 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manualised nurse-led telephone support in people with Multiple Sclerosis, run by University of Dublin, Trinity College at 2 sites in Ireland.
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 6 inclusion and 3 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Support person/caregiver Self-efficacy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302431, which also lists 5 linked publications.
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 3 Dec 2014.