Nurse-Led Manualized Telephone Support Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Dublin, Trinity College
Sponsor:
Information provided by (Responsible Party):
Margarita Corry, University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT01302431
First received: February 23, 2011
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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 Intervention
Multiple Sclerosis
Other: Manualised nurse-led telephone support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:
  • Support person/caregiver Self-efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This outcome measures support person/caregiver self-efficacy for obtaining respite and self-efficacy in problem solving


Secondary Outcome Measures:
  • Support person/caregiver preparedness to care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This outcome measure measures how well support persons/caregivers feel prepared to care for a PwMS


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

For PwMS:

  • PwMS who cannot nominate a caregiver
  • PwMS who are already engaged in similar research
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302431

Contacts
Contact: Margarita Corry 003538963008

Locations
Ireland
Not yet recruiting
Dublin, Ireland
Principal Investigator: Margarita Corry         
Site 1 Recruiting
Dublin, Ireland, 24
Sponsors and Collaborators
University of Dublin, Trinity College
  More Information

Publications:
Responsible Party: Margarita Corry, Research fellow, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01302431     History of Changes
Other Study ID Numbers: NLTSI
Study First Received: February 23, 2011
Last Updated: August 21, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Dublin, Trinity College:
experimental
intervention
nurse-led
nurse specialist
multiple sclerosis
support of caregivers

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014