Nurse-Led Manualized Telephone Support Intervention
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|ClinicalTrials.gov Identifier: NCT01302431|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Manualised nurse-led telephone support||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|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|
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
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01302431
|Dublin, Ireland, 24|