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Nurse-Led Manualized Telephone Support Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Dublin, Trinity College.
Recruitment status was  Recruiting
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

February 23, 2011
August 21, 2012
April 2011
October 2013   (final data collection date for primary outcome measure)
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
Caregiver Self-efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This outcome measures caregiver self-efficacy for obtaining respite and self-efficacy in problem solving
Complete list of historical versions of study NCT01302431 on ClinicalTrials.gov Archive Site
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
Caregiver preparedness to care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This outcome measure measures how well caregivers feel prepared to care
Not Provided
Not Provided
 
Nurse-Led Manualized Telephone Support Intervention
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Multiple Sclerosis
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
  • 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
    Intervention: Other: Manualised nurse-led telephone support
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Margarita Corry 003538963008
Ireland
 
NCT01302431
NLTSI
Yes
Margarita Corry, University of Dublin, Trinity College
University of Dublin, Trinity College
Not Provided
Not Provided
University of Dublin, Trinity College
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP