Individualised Informal Caregiver Training for Palliative Care at Home

Palliative Care Clinical Trial

Official title:

Feasibility Study: Improving Caregiver Confidence in Their Ability to Look After Patients With Palliative Care Needs, Using Focused One to One Training in the Home

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02591693
• Other study ID #: REC number 14/SC/1104
• Status: Terminated
• Phase: N/A
• First received: September 29, 2015
• Last updated: June 1, 2016
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a training intervention to improve caregiver confidence for family caregivers of patients with palliative care needs at home, is acceptable to patients and their caregivers.

Description:

Many patients with terminal illnesses rely on friends and family for much of their practical day to day care. These friends and family members often lack the skills and confidence to carry out these tasks and studies have shown that many would want more support. Studies have also shown that many patients feel they are a burden.

This study involves carers receiving training to learn the skills they need to care for their loved one. Adult patients with terminal illnesses, currently receiving care from a specified hospice in the South East of England, who have a friend or family member caring for them at home are eligible to be referred for this study.

The training of the carer will be carried out over three sessions by an Occupational Therapist in the patient's own home.The training will focus on goals that the patient and carer have chosen together.

The carer will be asked to complete before and after questionnaires and some will be asked to take part in interviews to see how they felt about the study.

The potential benefits of this study are to increase carer confidence in caring for their loved one.

The overall aim of this study is to test out the research method to see if patients and carers find this training and the outcome measures acceptable. If they do then the investigators plan to learn from this study to design a larger randomised control trial which would be the best way of knowing for sure whether and in what ways this training is helpful.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient currently at home, reliant on family/friends (lay carers) some or all of the time to help with practical or personal care.

• The carer is aged 18 years or over.

• The carer and the patient have the capacity to consent to being involved in the study.

Exclusion Criteria:

• There is a current plan in place for all care to be provided by paid carers full time.

• The patient currently receiving more than one contact with Hospice Specialist Occupational Therapy or is likely to develop needs requiring more than one contact Hospice Occupational Therapy over the four week study intervention period.

• Patients and carers who are not able to speak or understand adequate English for consent to be obtained, to be able to undertake carer training and to complete the study outcome measures.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Caregiver training
Occupational therapy training focuses on improving confidence to manage practical aspects of care in areas of daily life important to patient and caregiver, in which caregiver reports or anticipates low levels of confidence.

Locations

Country	Name	City	State
United Kingdom	Sir Michael Sobell House Hospice	Oxford	Oxfordshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Oxford	Oxford Brookes University, Oxford University Hospitals NHS Trust, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care utilisation	A record of unplanned or emergency care accessed by patient over course of study period will be completed by carers.	4-6 weeks	No
Other	Acceptability	Carer and patient questionnaires, carer qualitative interviews, occupational therapist report	4-6 weeks	No
Other	Age	Patient and carer demographics will be collected.	Baseline	No
Other	Gender		Baseline	No
Other	Diagnosis	Diagnosis of patient	Baseline	No
Other	Health status	Self reported health status of carer	Baseline	No
Other	Co-morbidities	Other medical conditions	Baseline	No
Other	Social Circumstances	Lives alone, lives with, type of housing,	Baseline	No
Primary	Recruitment, retention, attrition, missing data rates	To evaluate feasibility of study	6 weeks post recruitment	No
Secondary	Preparedness for caregiving scale	Validated for carers of patients with dementia but is used in palliative care settings. Eight items evaluate carer preparedness to care across multiple domains of caregiving. Items rated on a 5 point scale. Low scores indicate less preparedness.	Baseline and 4-6 weeks	No
Secondary	Caregiver Burden Scale at End of Life	Validated for use in carers looking after patients with chronic illness. 14 items measured on a 5 point scale evaluate perceived difficulty in completing tasks. High scores indicate greater burden.	Baseline and 4-6 weeks	No
Secondary	Modified Caregiver Strain Index	13 item tool developed for carers looking after older adults living in community based settings. Items measure strain related to care provision in financial, physical, psychological, social or personal domains scored on a three point scale. High scores indicate higher levels of strain.	Baseline and 4-6 weeks	No
Secondary	Carer Confidence Scale	Non validated. Developed by research team as no existing tools measure carer confidence in palliative care settings. A single question asks carers to rate their confidence to care on a 5 point scale. Higher scores indicate greater confidence.	Baseline and 4-6 weeks	No