Palliative CareNCT02591693
Individualised Informal Caregiver Training for Palliative Care at Home
A study testing Caregiver training in people with Palliative Care, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Caregiver training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sir Michael Sobell House Hospice
Oxford, Oxfordshire, OX37LE
About this study
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
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.
Read the detailed 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.
- Conditions
- Palliative Care
- Being tested
- Caregiver training
- Keywords
- Family Caregivers, Occupational Therapy, Activities of Daily Living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Training | Experimental | Three home visits by a specialist occupational therapist, each lasting 1-2 hours. Assessment and training to confidently achieve up to three goals relating to practical activities of daily living identified by patient and caregiver.
On-going usual care from multi-professional team at hospice. Receives: Behavioral: Caregiver training |
| Usual Care | No intervention | On-going usual care from multi-professional team at hospice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment, retention, attrition, missing data rates
To evaluate feasibility of study
Measured: 6 weeks post recruitment
Secondary outcomes (4)
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.
Measured: Baseline and 4-6 weeks
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.
Measured: Baseline and 4-6 weeks
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.
Measured: Baseline and 4-6 weeks
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.
Measured: Baseline and 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Trial OT left post due to significant personal circumstances. Study team unable to recruit new OT to post in time frame available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oxford Brookes University, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Bee Wee, MB BCh PhD, Study chair, Oxford University Hospitals NHS Trust and University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591693
- Sponsor's protocol ID
- REC number 14/SC/1104
- Status last verified
- Jun 2016
- First submitted
- 29 Sep 2015
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02591693
- Acronym / sponsor ID
- REC number 14/SC/1104
- Conditions
- Palliative Care
- Keywords
- Family Caregivers, Occupational Therapy, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial OT left post due to significant personal circumstances. Study team unable to recruit new OT to post in time frame available.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oxford Brookes University, University of Southampton
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver Training | Experimental | Behavioral: Caregiver trainingThree home visits by a specialist occupational therapist, each lasting 1-2 hours. Assessment and training to confidently achieve up to three goals relating to practical activities of daily living identified by patient and caregiver. On-going usual care from multi-professional team at hospice. |
| Usual Care | No intervention | –On-going usual care from multi-professional team at hospice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver trainingOccupational 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. | Behavioural | Caregiver Training |
Primary outcome
Recruitment, retention, attrition, missing data rates
Time frame: 6 weeks post recruitment
To evaluate feasibility of study
4 secondary outcomes
Preparedness for caregiving scale
Time frame: Baseline and 4-6 weeks
Caregiver Burden Scale at End of Life
Time frame: Baseline and 4-6 weeks
Modified Caregiver Strain Index
Time frame: Baseline and 4-6 weeks
Carer Confidence Scale
Time frame: Baseline and 4-6 weeks
Results and safety
The study was stopped early (reason given: Trial OT left post due to significant personal circumstances. Study team unable to recruit new OT to post in time frame available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bee Wee, MB BCh PhD study chair
Oxford University Hospitals NHS Trust and University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver training in people with Palliative Care, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Trial OT left post due to significant personal circumstances. Study team unable to recruit new OT to post in time frame available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment, retention, attrition, missing data rates (time frame: 6 weeks post recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.