Family Caregiving for a Palliative PatientCSNATNCT02261935
Supporting Family Caregivers of Palliative Patients at Home: the Carer Support Needs Assessment Intervention
A study testing Existing home care nursing practice and Practice support tool intervention in people with Family Caregiving for a Palliative Patient, run by Kelli Stajduhar at 1 site in Canada.
Trial summary
In this project the investigators will train home care nurses to use the Carer Support Needs Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then compare the family caregivers' quality of life, burden and other outcomes to a group of family caregivers whose home care nurse is not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Caregiving for a Palliative Patient
- What is being tested?
- Existing home care nursing practice and Practice support tool intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to 20 Dec 2017
- 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
- For home care nurse participants:
- registered or licensed home care nurse at one of the following Vancouver Island Health Authority Home and Community Care offices: Victoria, Esquimalt/Westshore, Peninsula, Royal Oak, Duncan/Ladysmith, Oceanside, Comox Valley, Campbell River
- practiced in home care for > 6 months
- work a minimum of 10 shifts per month
- communicate well in English
- For family caregiver participants:
Show all 9Show fewer
- currently a family caregiver of palliative patient at home
- patient and family caregiver must be 18 years of age or older
- must communicate well in English
Who cannot join
- For family caregiver participants
- diagnosed cognitive impairment
- identified safety risks in the home care environment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Island Health Home and Community Care
Victoria, British Columbia, V8T 3P7
About this study
Official title: Clustered, Randomized, Controlled Trial of the Home Care Nurse Carer Support Needs Assessment Practice Tool With Family Caregivers of Palliative Patients at Home
In this project the investigators will train home care nurses to use the Carer Support Needs Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then compare the family caregivers' quality of life, burden and other outcomes to a group of family caregivers whose home care nurse is not using the CSNAT (control group). Findings will allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and address family caregiver support needs in palliative home care.
Read the detailed description
Caregiving places considerable burdens on family caregivers (FCG). While burden has been studied as a FCG outcome, it is also a predictor of other outcomes, including FCG quality of life (QoL). We have adapted a model of caregiver burden to hypothesize the various mechanisms by which addressing support needs may contribute to FCG QoL. In this model, support needs are closely associated with FCGs' perceived social support and preparedness for caregiving. These variables operate as (partial) mediators of the relationships between primary stressors, including patient functional dependence and symptom distress, and secondary appraisals, such as the perceived burden associated with caregiving, which, in turn influences FCGs QoL. The model further posits that FCGs' primary appraisal of patient caregiving needs (e.g., amount of care provided) is influenced by the functional dependence and symptom distress of the patient, and in turn influences perceived support, preparedness for caregiving, FCG burden, and, ultimately, FCG QoL. These variables are associated with a variety of demographic and health-related characteristics of the caregiver and patient.
Within the context of this conceptual framework outlined above, the CSNAT intervention is viewed as a mediator of the relationships between primary stressors and appraisals and FCG QoL (primary outcome). Also, the CSNAT intervention would lead to enhanced social support, preparedness, and reduced caregiver burden.
A clustered randomized control trial (RCT) design will be used to ascertain the effectiveness of the CSNAT as an intervention to improve the QoL of FCGs of patients receiving palliative care at home. Participating home care nurses will be randomized to one of two comparator groups (usual care and intervention) and the FCGs of their patients will be assigned to the corresponding comparator group. Data will additionally be collected over the same time frame and in the same manner from a non-randomized comparison usual care comparator group from a separate home care site where no nurses will be delivering the intervention, to help interpret the results (e.g., to determine the extent to which contamination may be have occurred). Update - August 31, 2015 - Due to low recruitment the non-randomized, comparison, usual care, comparator group has been discontinued.
Update - December 22, 2016 - Due to home care workloads of participant nurses and home care visit schedules in some participating home care offices, delivery of the intervention will be done by a dedicated study nurse (in some offices only). In these offices, family caregivers will continue to be assigned based on the randomized group assignment of their home care nurse. The dedicated study nurse will meet separately with FCGs who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse so that the home care nurse can incorporate this into the home care plan for the patient and patient's family. In home care offices that are not part of this change in procedures, the home care nurses in the intervention group will continue to deliver the CSNAT intervention during home care visits as before.
Our specific hypotheses are as follows:
- Hypothesis 1: The use of the CSNAT as a practice support tool intervention will lead to improved FCG QoL during the time prior to the patients' death and in bereavement.
- Hypothesis 2: The use of the CSNAT as a practice support tool intervention will contribute to the following secondary outcomes in FCGs during the time prior to the patient's death: enhanced perceived social support, improved preparedness to provide care and reduced caregiving burden.
- Hypothesis 3: CSNAT use during home care of patient before death will reduce grief symptoms during bereavement, among FCGs.
In addition to the RCT, qualitative and quantitative research will be conducted to understand the process related to implementing the CSNAT intervention in palliative home care and to explain the treatment results. We will specifically address the following questions:
- How are the CSNAT support needs being documented and met by home care nurses?
- How do home care nurses experience the use of the CSNAT in their daily practice?
- How comfortable are FCGs speaking to home care nurses about their own personal needs?
- To what extent are the relationships in the hypothesized conceptual framework supported?
- What is the relative importance of different CSNAT support needs with respect to FCG QoL and health during the illness trajectory, and the presence of post-bereavement grief symptoms?
- Being tested
- Existing home care nursing practice, Practice support tool intervention
- Keywords
- Family caregiver, Home care nursing practice, Palliative care, End of life care, Family caregiver quality of life, Family caregiver grief symptoms, Family caregiver burden, Family caregiver preparedness for caregiving, Family caregiver perceived social supports, Family caregiver health status, Family caregiver satisfaction with healthcare provided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Existing home care nursing practiceOther
Home care nurses in this comparator group will provide "care as per usual" to their patients and family caregivers. The family is seen as the unit of care but no formal assessment of the caregiver will be done.
Practice support tool interventionOther
Also called CSNAT
The intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.
The completed CSNAT tool will be kept in the patient chart and will be integrated into the care provided by the nurse.
Update - December 22, 2016 - In some offices only, the CSNAT will be administered by a separate study nurse. Findings will be communicated to the home care nurse to inform the documenting, monitoring and addressing of family caregiver support needs.
| Study group | Role | What they receive |
|---|---|---|
| Existing Home Care Nursing Practice | Active comparator | Home care nurses provide care based on existing home care practice Receives: Other: Existing home care nursing practice |
| Practice Support Tool Intervention | Experimental | The practice support tool intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.
Update - December 22, 2016 - In some home care offices only, a study nurse will meet with family caregivers who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse, and incorporated by the home care nurse into the home care plan for the patient and patient's family. Receives: Other: Practice support tool intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trajectory of change in family caregiver quality of life while caring for a palliative patient at home, as measured by the Quality of Life in Life Threatening Illness - Family carer version (QOLLTI-F) total score
The QOLLTI-F is a self-report measure of family caregiver quality of life. It is composed of 16 items which assess the following 7 domains: state of carer, patient well-being, quality of care, outlook, environment, finances and relationships. Additional exploratory analyses will also be conducted on these subscales.
Measured: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Family caregiver grief symptoms after patient death, as measured by the Texas Revised Inventory of Grief (TRIG) subscale scores
The TRIG is a 21 item scale designed to assess grief symptoms. It relates to two points of time: past (immediate of shortly after the death) and present (the time of data collection). The 2 subscales measure a) feelings and actions at the time of the death and b) present feelings.
Measured: 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)
Secondary outcomes (6)
Family caregiver quality of life after patient death, as measured by the Quality of Life in Life Threatening Illness - Family carer version Global Single-Item Scale (QOLLTI-F SIS)
The QOLLTI-F is a self-report measure of family caregiver quality of life. We will be using the score from the single item score measuring global quality of life (Part A).
Measured: 12 weeks after patient death
Trajectory of change in family caregiver burden while caring for a palliative patient at home, as measured by the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Scale
A 25 item measure of family caregiver's positive and negative appraisals of caregiving, including strain, positive appraisals, distress, and family wellbeing.
Measured: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver preparedness for caregiving while caring for a palliative patient at home, as measured by the Family Caregiving Inventory: Preparedness Scale
A caregiver self-rated instrument that consists of 8 items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving.
Measured: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver perceived social supports while caring for a palliative patient at home, as measured by the Medical Outcome Survey (MOS) Social Support Survey
Overall Support Index determined using the mean from 18 items within four sub-measures and the mean from the additional item; (a) emotional/information support, (b) tangible support, (c) affectionate support, and (d) positive social interaction support. Designed to assess the perceived availability of social support.
Measured: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver health status and mental health status while caring for a palliative patient at home, as measured by the Veterans RAND 12 item health survey
A 14 item scale, 12 of which are a sampling of items from each of the eight domains of health (physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health). The eight scales are summarized into two summary scores, physical (PCS) and mental (MCS).
Measured: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver satisfaction with healthcare provided while caring for a palliative patient at home until death, as measured by the Canadian Health Care Evaluation Project - Caregiver Questionnaire (CANHELP LITE)
Overall score calculated as the unweighted average of all 21 items (22 for the bereavement version which will be used after patient death) answered. A tool to evaluate satisfaction with care for family members of older patients with life threatening illnesses up to and until death.
Measured: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first), 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family Caregiving for a Palliative PatientStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelli Stajduhar
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network, Canadian Cancer Society (CCS)
- Responsible party
- Sponsor-investigator, Kelli Stajduhar, University of Victoria
- Investigators
- Kelli I Stajduhar, PhD, Principal investigator, University of VictoriaRichard G Sawatzky, PhD, Principal investigator, Trinity Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261935
- Sponsor's protocol ID
- TVN-core2013-01 CCSRI-702597
- Acronym
- CSNAT
- Status last verified
- Mar 2018
- First submitted
- 30 Sep 2014
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
PubMed 35802350
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clustered, Randomized, Controlled Trial of the Home Care Nurse Carer Support Needs Assessment Practice Tool With Family Caregivers of Palliative Patients at Home
- ClinicalTrials.gov ID
- NCT02261935
- Acronym / sponsor ID
- CSNAT / TVN-core2013-01 CCSRI-702597
- Keywords
- Family caregiver, Home care nursing practice, Palliative care, End of life care, Family caregiver quality of life, Family caregiver grief symptoms, Family caregiver burden, Family caregiver preparedness for caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Kelli StajduharUniversity, hospital or other
- Collaborators
- Canadian Frailty Network, Canadian Cancer Society (CCS)
- Study start
- Sep 2014 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 10 Oct 2014 (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.
In this project the investigators will train home care nurses to use the Carer Support Needs Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then compare the family caregivers' quality of life, burden and other outcomes to a group of family caregivers whose home care nurse is not using the CSNAT (control group). Findings will allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and address family caregiver support needs in palliative home care.
Detailed description
Caregiving places considerable burdens on family caregivers (FCG). While burden has been studied as a FCG outcome, it is also a predictor of other outcomes, including FCG quality of life (QoL). We have adapted a model of caregiver burden to hypothesize the various mechanisms by which addressing support needs may contribute to FCG QoL. In this model, support needs are closely associated with FCGs' perceived social support and preparedness for caregiving. These variables operate as (partial) mediators of the relationships between primary stressors, including patient functional dependence and symptom distress, and secondary appraisals, such as the perceived burden associated with caregiving, which, in turn influences FCGs QoL. The model further posits that FCGs' primary appraisal of patient caregiving needs (e.g., amount of care provided) is influenced by the functional dependence and symptom distress of the patient, and in turn influences perceived support, preparedness for caregiving, FCG burden, and, ultimately, FCG QoL. These variables are associated with a variety of demographic and health-related characteristics of the caregiver and patient.
Within the context of this conceptual framework outlined above, the CSNAT intervention is viewed as a mediator of the relationships between primary stressors and appraisals and FCG QoL (primary outcome). Also, the CSNAT intervention would lead to enhanced social support, preparedness, and reduced caregiver burden.
A clustered randomized control trial (RCT) design will be used to ascertain the effectiveness of the CSNAT as an intervention to improve the QoL of FCGs of patients receiving palliative care at home. Participating home care nurses will be randomized to one of two comparator groups (usual care and intervention) and the FCGs of their patients will be assigned to the corresponding comparator group. Data will additionally be collected over the same time frame and in the same manner from a non-randomized comparison usual care comparator group from a separate home care site where no nurses will be delivering the intervention, to help interpret the results (e.g., to determine the extent to which contamination may be have occurred). Update - August 31, 2015 - Due to low recruitment the non-randomized, comparison, usual care, comparator group has been discontinued.
Update - December 22, 2016 - Due to home care workloads of participant nurses and home care visit schedules in some participating home care offices, delivery of the intervention will be done by a dedicated study nurse (in some offices only). In these offices, family caregivers will continue to be assigned based on the randomized group assignment of their home care nurse. The dedicated study nurse will meet separately with FCGs who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse so that the home care nurse can incorporate this into the home care plan for the patient and patient's family. In home care offices that are not part of this change in procedures, the home care nurses in the intervention group will continue to deliver the CSNAT intervention during home care visits as before.
Our specific hypotheses are as follows:
- Hypothesis 1: The use of the CSNAT as a practice support tool intervention will lead to improved FCG QoL during the time prior to the patients' death and in bereavement.
- Hypothesis 2: The use of the CSNAT as a practice support tool intervention will contribute to the following secondary outcomes in FCGs during the time prior to the patient's death: enhanced perceived social support, improved preparedness to provide care and reduced caregiving burden.
- Hypothesis 3: CSNAT use during home care of patient before death will reduce grief symptoms during bereavement, among FCGs.
In addition to the RCT, qualitative and quantitative research will be conducted to understand the process related to implementing the CSNAT intervention in palliative home care and to explain the treatment results. We will specifically address the following questions:
- How are the CSNAT support needs being documented and met by home care nurses?
- How do home care nurses experience the use of the CSNAT in their daily practice?
- How comfortable are FCGs speaking to home care nurses about their own personal needs?
- To what extent are the relationships in the hypothesized conceptual framework supported?
- What is the relative importance of different CSNAT support needs with respect to FCG QoL and health during the illness trajectory, and the presence of post-bereavement grief symptoms?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Existing Home Care Nursing Practice | Active comparator | Other: Existing home care nursing practiceHome care nurses provide care based on existing home care practice |
| Practice Support Tool Intervention | Experimental | Other: Practice support tool interventionThe practice support tool intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs. Update - December 22, 2016 - In some home care offices only, a study nurse will meet with family caregivers who are in the intervention group to deliver the CSNAT intervention. Information arising from the CSNAT about family caregivers' support needs will be communicated by the study nurse to the home care nurse, and incorporated by the home care nurse into the home care plan for the patient and patient's family. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- registered or licensed home care nurse at one of the following Vancouver Island Health Authority Home and Community Care offices: Victoria, Esquimalt/Westshore, Peninsula, Royal Oak, Duncan/Ladysmith, Oceanside, Comox Valley, Campbell River
- practiced in home care for > 6 months
- work a minimum of 10 shifts per month
- communicate well in English
- currently a family caregiver of palliative patient at home
Key exclusion criteria (3 listed)
- For family caregiver participants
- diagnosed cognitive impairment
- identified safety risks in the home care environment
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 |
|---|---|---|
| Existing home care nursing practiceHome care nurses in this comparator group will provide "care as per usual" to their patients and family caregivers. The family is seen as the unit of care but no formal assessment of the caregiver will be done. | Other | Existing Home Care Nursing Practice |
| Practice support tool interventionAlso: CSNATThe intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs. The completed CSNAT tool will be kept in the patient chart and will be integrated into the care provided by the nurse. Update - December 22, 2016 - In some offices only, the CSNAT will be administered by a separate study nurse. Findings will be communicated to the home care nurse to inform the documenting, monitoring and addressing of family caregiver support needs. | Other | Practice Support Tool Intervention |
Primary outcome
Trajectory of change in family caregiver quality of life while caring for a palliative patient at home, as measured by the Quality of Life in Life Threatening Illness - Family carer version (QOLLTI-F) total score
Time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
The QOLLTI-F is a self-report measure of family caregiver quality of life. It is composed of 16 items which assess the following 7 domains: state of carer, patient well-being, quality of care, outlook, environment, finances and relationships. Additional exploratory analyses will also be conducted on these subscales.
Family caregiver grief symptoms after patient death, as measured by the Texas Revised Inventory of Grief (TRIG) subscale scores
Time frame: 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)
The TRIG is a 21 item scale designed to assess grief symptoms. It relates to two points of time: past (immediate of shortly after the death) and present (the time of data collection). The 2 subscales measure a) feelings and actions at the time of the death and b) present feelings.
6 secondary outcomes
Family caregiver quality of life after patient death, as measured by the Quality of Life in Life Threatening Illness - Family carer version Global Single-Item Scale (QOLLTI-F SIS)
Time frame: 12 weeks after patient death
Trajectory of change in family caregiver burden while caring for a palliative patient at home, as measured by the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Scale
Time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver preparedness for caregiving while caring for a palliative patient at home, as measured by the Family Caregiving Inventory: Preparedness Scale
Time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver perceived social supports while caring for a palliative patient at home, as measured by the Medical Outcome Survey (MOS) Social Support Survey
Time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver health status and mental health status while caring for a palliative patient at home, as measured by the Veterans RAND 12 item health survey
Time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)
Trajectory of change in family caregiver satisfaction with healthcare provided while caring for a palliative patient at home until death, as measured by the Canadian Health Care Evaluation Project - Caregiver Questionnaire (CANHELP LITE)
Time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first), 12 weeks after patient death (will not be collected if patient death does not occur within the first 92 weeks of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 35802350Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
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.
Kelli I Stajduhar, PhD principal investigator
University of Victoria
Richard G Sawatzky, PhD principal investigator
Trinity Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Existing home care nursing practice and Practice support tool intervention in people with Family Caregiving for a Palliative Patient, run by Kelli Stajduhar at 1 site in Canada.
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 9 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: finished, as of the sponsor's last update on 20 Mar 2018. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trajectory of change in family caregiver quality of life while caring for a palliative patient at home, as measured by the Quality of Life in Life Threatening Illness - Family carer version (QOLLTI-F) total score (time frame: Baseline, 8 week intervals up to 96 weeks or patient death (whichever comes first)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261935, which also lists 1 linked publication.
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 20 Mar 2018.