MedDataX Logo

Nurse-Led Manualized Telephone Support Intervention

NCT ID: NCT01302431

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Manualised nurse-led telephone support

Intervention Type OTHER

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Dublin, Trinity College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margarita Corry

Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site 1

Dublin, , Ireland

Site Status

Dublin, , Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20228893 (View on PubMed)

Stewart 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.

Reference Type BACKGROUND
PMID: 11223062 (View on PubMed)

Bormann 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.

Reference Type BACKGROUND
PMID: 19752637 (View on PubMed)

Bank 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.

Reference Type BACKGROUND
PMID: 16452294 (View on PubMed)

Corry 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.

Reference Type BACKGROUND
PMID: 19077062 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NLTSI

Identifier Type: -

Identifier Source: org_study_id