NCT02591693

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

September 29, 2015

Last Update Submit

June 1, 2016

Conditions

Keywords

Family CaregiversOccupational TherapyActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Recruitment, retention, attrition, missing data rates

    To evaluate feasibility of study

    6 weeks post recruitment

Secondary Outcomes (4)

  • Preparedness for caregiving scale

    Baseline and 4-6 weeks

  • Caregiver Burden Scale at End of Life

    Baseline and 4-6 weeks

  • Modified Caregiver Strain Index

    Baseline and 4-6 weeks

  • Carer Confidence Scale

    Baseline and 4-6 weeks

Other Outcomes (8)

  • Health care utilisation

    4-6 weeks

  • Acceptability

    4-6 weeks

  • Age

    Baseline

  • +5 more other outcomes

Study Arms (2)

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.

Behavioral: Caregiver training

Usual Care

NO INTERVENTION

On-going usual care from multi-professional team at hospice.

Interventions

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.

Caregiver Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Michael Sobell House Hospice

Oxford, Oxfordshire, OX37LE, United Kingdom

Location

Study Officials

  • Bee Wee, MB BCh PhD

    Oxford University Hospitals NHS Trust and University of Oxford

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 29, 2015

Study Start

August 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations