COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Nurse-Led Manualized Telephone Support Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01302431
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Margarita Corry, University of Dublin, Trinity College

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Manualised nurse-led telephone support Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Exploratory Randomized Controlled Trial of a Manualized, Nurse-led, Telephone Intervention Support Service for Support Persons of People With Multiple Sclerosis
Study Start Date : April 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nurse-Led Manualised Telephone support
Participants assigned to this arm of the study will receive 4 nurse-led telephone support calls over a three month time-frame
Other: Manualised nurse-led telephone support
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

No Intervention: Usual care
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Support person/caregiver preparedness to care [ Time Frame: 3 months ]
    This outcome measure measures how well support persons/caregivers feel prepared to care for a PwMS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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.

Exclusion Criteria:

For PwMS:

  • PwMS who cannot nominate a caregiver
  • PwMS who are already engaged in similar research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01302431

Layout table for location information
Site 1
Dublin, Ireland, 24
Dublin, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
Layout table for additonal information
Responsible Party: Margarita Corry, Research fellow, University of Dublin, Trinity College Identifier: NCT01302431    
Other Study ID Numbers: NLTSI
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Margarita Corry, University of Dublin, Trinity College:
nurse specialist
multiple sclerosis
support of caregivers
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases