Caregiver StressNCT07749482
Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction
A study testing CSNAT-I in people with Caregiver Stress and Caregiver Health Related QOL, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study will evaluate the feasibility, acceptability, and preliminary effects of the Carer Support Needs Assessment Tool (CSNAT) intervention for family caregivers of older adults receiving home-based primary care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress, Caregiver Health Related QOL, Caregiver Mental Health
- What is being tested?
- CSNAT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older.
- Self-report as providing consistent care to an older adult who receives medical home visits by a nurse practitioner as part of the UTMB Home-Based Primary Care (HBPC) Program.
- Provides consistent care to an older adult which includes one or more of the following: a) Assistance with activities of daily living (ADLs), b) Medication management, c) Medical or nursing-related tasks
- Provides consistent care to an adult age 65 years or older.
- Be able to read, speak, and understand English.
Who cannot join
- Does not provide consistent home care (including assistance with ADLs, medication management, or medical/nursing tasks)
- Provides care to a patient who is under 65 years of age
- Provides care to a patient not enrolled in the UTMB Health HBPC program
- Provides care to a patient not receiving in-home visits by a nurse practitioner.
- Is younger than 18 years of age
- Is unable to read or speak English
- Has an obvious neurological or psychiatric condition that may affect participation
- Has communication deficits that may impact ability to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Karen E. Schlag, PhD, 409-772-1011, keschlag@utmb.edu
About this study
Official title: Applying a Family Caregiver Supports Needs Assessment Tool in Home-based Primary Care: An Approach to Elder Mistreatment Risk Reduction and Prevention
This study will evaluate the feasibility, acceptability, and preliminary effects of the Carer Support Needs Assessment Tool (CSNAT) intervention for family caregivers of older adults receiving home-based primary care. The CSNAT is a structured, caregiver-centered approach designed to identify caregiver support needs and facilitate supportive problem-solving conversations between clinicians and family caregivers.
Family caregivers will be assigned to either the CSNAT intervention or a comparison group receiving usual care. Feasibility will be evaluated through participant recruitment, retention, and intervention adherence. Acceptability will be assessed through qualitative interviews with caregivers who participate in the intervention.
Read more
The study will also examine the preliminary effects of the CSNAT intervention on caregiver outcomes, including caregiver strain, physical well-being, mental well-being, and emotional management. In addition, the study will explore whether improvements in caregiver well-being are associated with a reduced risk of situations that may contribute to harm or neglect of the older adult receiving care.
This pilot study will provide information on the practicality of implementing the CSNAT intervention in home-based primary care and will inform the design of future larger-scale studies.
Read the detailed description
Family caregivers play a crucial role in the care of older adults with health and daily living needs at home. At the same time, caregiving in this context can be stressful and demanding, and family members can experience strain, poor health, and unmet support needs. These circumstances can further impact the older adults they care for, including creating unwanted risks to their health and safety. Caregivers of patients receiving home-based primary care may be especially likely to experience these challenges because many patients have multiple health conditions and require extensive support.
The Carer Support Needs Assessment Tool (CSNAT) is a structured approach where caregivers identify and prioritize areas where they need support by responding to the CSNAT questionnaire (i.e., tool). The tool covers 15 areas related to both caregiving responsibilities and caregivers' own well-being. After completing the questionnaire/tool, caregivers use their responses to the CSNAT to shape discussions about their care needs with a healthcare provider. Together, the caregiver and clinician create a plan to address identified support needs and later review progress and any additional needs.
This study will evaluate whether the CSNAT approach can be successfully used with family caregivers of older adults receiving home-based primary care. Eighty caregivers will be randomly assigned to either a CSNAT intervention group or a usual-care control group. Caregivers in the intervention group will complete the CSNAT, participate in a support planning discussion with a nurse practitioner, and take part in a follow-up discussion approximately one month later. Caregivers in the control group will receive usual care, which may include informal conversations with their healthcare provider about caregiving needs.
Researchers will assess the practicality and acceptability of the CSNAT approach by examining recruitment, participation, retention, and completion of study activities. The study will also collect information on caregiver strain, caregiver physical and mental well-being, and factors related to risk of elder mistreatment before and after the study period. In addition, interviews with a subset of caregivers in the intervention group will be conducted to better understand their experiences with the CSNAT approach.
- Conditions
- Caregiver Stress, Caregiver Health Related QOL, Caregiver Mental Health, Caregiver Health Status, Recruitment of Participants, Elder Mistreatment
- Being tested
- CSNAT-I
- Keywords
- elder mistreatment, caregiver support, homebased primary care
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSNAT-IBehavioural
The CSNAT intervention is a structured, caregiver-centered approach that identifies caregiver support needs and facilitates clinician-led support and problem-solving discussions. The intervention includes completion of the CSNAT assessment, collaborative care planning with a nurse practitioner, and a follow-up review of action plan implementation approximately one month later. Audio recordings may be collected, with participant consent, to assess intervention fidelity.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Carer Support Needs Assessment Tool (CSNAT) | Experimental | The Carer Support Needs Assessment Tool (CSNAT) is a caregiver-centered intervention designed to identify and address family caregiver support needs. The intervention includes completion of the CSNAT assessment followed by structured support and problem-solving discussions with a clinician to prioritize needs, develop action plans, and connect caregivers with available resources. Receives: Behavioral: CSNAT-I |
| Usual Care Control Group | No intervention | Participants in this arm will receive usual home-based primary care services. As part of standard practice, family caregivers may engage in informal, ad hoc conversations with the visiting nurse practitioner regarding caregiving needs and concerns during routine home care visits for the older adult receiving care. Caregivers in this arm will not receive the structured Carer Support Needs Assessment Tool (CSNAT) intervention. Participants will complete study assessments at baseline and post-intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Recruitment feasibility will be assessed by the time from identification of a potential participant to enrollment, participant refusal rate, and average time required to enroll 20 caregivers per study arm.
Measured: During participant recruitment (up to 12 months).
Participant Acceptability of CSNAT Intervention
Acceptability of the CSNAT intervention will be assessed through semi-structured qualitative interviews conducted with intervention participants who complete the study intervention. Interviews will explore: (1) caregiver experiences and caregiving-related stressors; (2) caregiver support needs; (3) participant experiences with and perceptions of the CSNAT intervention; and (4) barriers and facilitators to participation in the intervention. Interview data will be analyzed to identify themes related to the acceptability, perceived usefulness, and implementation of the intervention.
Measured: From posttest to two weeks following completion of the post-intervention assessment
Participant Retention
Retention will be assessed as the proportion of enrolled participants who complete both baseline and post-intervention assessments.
Measured: From enrollment through completion of post-intervention assessments (approximately 1 month).
Intervention Adherence
Intervention adherence will be assessed as the proportion of participants in the intervention arm who complete the CSNAT assessment and both planned support discussions with the nurse practitioner.
Measured: From intervention initiation through completion of the one-month follow-up discussion.
Secondary outcomes (6)
Change from Baseline in Caregiving Strain at One Month
Caregiving strain will be assessed using the 8-item Strain subscale of the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). The subscale evaluates caregiving burden related to role overload and role captivity. Items are rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). Responses are summed and/or averaged according to instrument scoring guidelines, with higher scores indicating lower levels of caregiving strain.
Outcome Measure: Change in caregiving strain score from baseline to 1 month. The change score will be calculated as the 1-month score minus the baseline score. Positive values indicate a reduction in caregiving strain, while negative values indicate an increase in caregiving strain.
Measured: Baseline and one month
Change From Baseline in Caregiver Physical Health at One Month
Assessed using the SF-12v2 Physical Component Summary (PCS). Higher scores indicate better physical health.
Measured: Baseline and one month
Change From Baseline in Caregiver Quality of Life at One Month
Caregiver quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), a 26-item validated instrument that measures quality of life across four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Items are rated on a 5-point Likert scale, with response options varying by item (e.g., 1 = very dissatisfied/not at all to 5 = very satisfied/completely). Domain scores are calculated according to instrument scoring guidelines, with higher scores indicating better quality of life.
Change in caregiver quality of life from baseline to 1 month, as measured by WHOQOL-BREF domain scores. Change scores will be calculated as the 1-month score minus the baseline score. Positive change values indicate improvement in quality of life.
Measured: Baseline to one month
Change from Baseline in Elder Mistreatment and Neglect Scores and Associations with Other Secondary Measures at One Month
Elder mistreatment will be assessed using the Potentially Harmful Behavior Scale (PHBS), a 10-item instrument that measures caregiver behaviors that may place the care recipient at risk of physical or psychological harm. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (all of the time), with higher scores indicating more frequent potentially harmful behaviors.
Caregiver neglect of the care recipient will be assessed using a 7-item Neglect Scale adapted to measure the frequency with which caregivers do not provide assistance with essential care needs, including medical care, activities of daily living, transportation, household tasks, nutrition, hygiene, and supervision. Items are rated on a 5-point Likert scale ranging from 1 (never/not relevant) to 5 (very frequently). Higher scores indicate a greater frequency of neglectful caregiving behaviors.
Change in elder mistreatment and neglect scores from baseline to 1
Measured: Baseline and one month
Change From Baseline in Caregiver Mental Health at One Month
Assessed using the SF-12v2 Mental Component Summary (MCS). Higher scores indicate better mental health.
Measured: Baseline to one month
Change From Baseline in Caregiver Depressive Symptoms at One Month
Assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start29 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), The University of Texas Health Science Center, Houston
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749482
- Sponsor's protocol ID
- 25-0116
- Other IDs
- P30AG086563
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual, de-identified participant data will be shared only with the study team and grant principal investigators for oversight purposes. No external sharing is planned.
Publications
Naumann VJ, Byrne GJ. WHOQOL-BREF as a measure of quality of life in older patients with depression. Int Psychogeriatr. 2004 Jun;16(2):159-73. doi: 10.1017/s1041610204000109.
PubMed 15318762Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Ayalon L. Reports of Elder Neglect by Older Adults, Their Family Caregivers, and Their Home Care Workers: A Test of Measurement Invariance. J Gerontol B Psychol Sci Soc Sci. 2015 May;70(3):432-42. doi: 10.1093/geronb/gbu051. Epub 2014 May 23.
PubMed 24859223Beach SR, Schulz R, Williamson GM, Miller LS, Weiner MF, Lance CE. Risk factors for potentially harmful informal caregiver behavior. J Am Geriatr Soc. 2005 Feb;53(2):255-61. doi: 10.1111/j.1532-5415.2005.53111.x.
PubMed 15673349Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006 Jul;15(7):613-22. doi: 10.1002/pon.1001.
PubMed 16287207Grande GE, Austin L, Ewing G, O'Leary N, Roberts C. Assessing the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in palliative home care: a stepped wedge cluster trial. BMJ Support Palliat Care. 2017 Sep;7(3):326-334. doi: 10.1136/bmjspcare-2014-000829. Epub 2015 Dec 30.
PubMed 26719349Aoun SM, Grande G, Howting D, Deas K, Toye C, Troeung L, Stajduhar K, Ewing G. The impact of the carer support needs assessment tool (CSNAT) in community palliative care using a stepped wedge cluster trial. PLoS One. 2015 Apr 7;10(4):e0123012. doi: 10.1371/journal.pone.0123012. eCollection 2015.
PubMed 25849348
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying a Family Caregiver Supports Needs Assessment Tool in Home-based Primary Care: An Approach to Elder Mistreatment Risk Reduction and Prevention
- ClinicalTrials.gov ID
- NCT07749482
- Acronym / sponsor ID
- 25-0116
- Conditions
- Caregiver Stress, Caregiver Health Related QOL, Caregiver Mental Health, Caregiver Health Status, Recruitment of Participants, Elder Mistreatment
- Keywords
- elder mistreatment, caregiver support, homebased primary care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), The University of Texas Health Science Center, Houston
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 Aug 2026 (actual)
- 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.
This study will evaluate the feasibility, acceptability, and preliminary effects of the Carer Support Needs Assessment Tool (CSNAT) intervention for family caregivers of older adults receiving home-based primary care. The CSNAT is a structured, caregiver-centered approach designed to identify caregiver support needs and facilitate supportive problem-solving conversations between clinicians and family caregivers.
Family caregivers will be assigned to either the CSNAT intervention or a comparison group receiving usual care. Feasibility will be evaluated through participant recruitment, retention, and intervention adherence. Acceptability will be assessed through qualitative interviews with caregivers who participate in the intervention.
The study will also examine the preliminary effects of the CSNAT intervention on caregiver outcomes, including caregiver strain, physical well-being, mental well-being, and emotional management. In addition, the study will explore whether improvements in caregiver well-being are associated with a reduced risk of situations that may contribute to harm or neglect of the older adult receiving care.
This pilot study will provide information on the practicality of implementing the CSNAT intervention in home-based primary care and will inform the design of future larger-scale studies.
Detailed description
Family caregivers play a crucial role in the care of older adults with health and daily living needs at home. At the same time, caregiving in this context can be stressful and demanding, and family members can experience strain, poor health, and unmet support needs. These circumstances can further impact the older adults they care for, including creating unwanted risks to their health and safety. Caregivers of patients receiving home-based primary care may be especially likely to experience these challenges because many patients have multiple health conditions and require extensive support.
The Carer Support Needs Assessment Tool (CSNAT) is a structured approach where caregivers identify and prioritize areas where they need support by responding to the CSNAT questionnaire (i.e., tool). The tool covers 15 areas related to both caregiving responsibilities and caregivers' own well-being. After completing the questionnaire/tool, caregivers use their responses to the CSNAT to shape discussions about their care needs with a healthcare provider. Together, the caregiver and clinician create a plan to address identified support needs and later review progress and any additional needs.
This study will evaluate whether the CSNAT approach can be successfully used with family caregivers of older adults receiving home-based primary care. Eighty caregivers will be randomly assigned to either a CSNAT intervention group or a usual-care control group. Caregivers in the intervention group will complete the CSNAT, participate in a support planning discussion with a nurse practitioner, and take part in a follow-up discussion approximately one month later. Caregivers in the control group will receive usual care, which may include informal conversations with their healthcare provider about caregiving needs.
Researchers will assess the practicality and acceptability of the CSNAT approach by examining recruitment, participation, retention, and completion of study activities. The study will also collect information on caregiver strain, caregiver physical and mental well-being, and factors related to risk of elder mistreatment before and after the study period. In addition, interviews with a subset of caregivers in the intervention group will be conducted to better understand their experiences with the CSNAT approach.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Carer Support Needs Assessment Tool (CSNAT) | Experimental | Behavioral: CSNAT-IThe Carer Support Needs Assessment Tool (CSNAT) is a caregiver-centered intervention designed to identify and address family caregiver support needs. The intervention includes completion of the CSNAT assessment followed by structured support and problem-solving discussions with a clinician to prioritize needs, develop action plans, and connect caregivers with available resources. |
| Usual Care Control Group | No intervention | –Participants in this arm will receive usual home-based primary care services. As part of standard practice, family caregivers may engage in informal, ad hoc conversations with the visiting nurse practitioner regarding caregiving needs and concerns during routine home care visits for the older adult receiving care. Caregivers in this arm will not receive the structured Carer Support Needs Assessment Tool (CSNAT) intervention. Participants will complete study assessments at baseline and post-intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older.
- Self-report as providing consistent care to an older adult who receives medical home visits by a nurse practitioner as part of the UTMB Home-Based Primary Care (HBPC) Program.
- Provides consistent care to an older adult which includes one or more of the following: a) Assistance with activities of daily living (ADLs), b) Medication management, c) Medical or nursing-related tasks
- Provides consistent care to an adult age 65 years or older.
- Be able to read, speak, and understand English.
Key exclusion criteria (8 listed)
- Does not provide consistent home care (including assistance with ADLs, medication management, or medical/nursing tasks)
- Provides care to a patient who is under 65 years of age
- Provides care to a patient not enrolled in the UTMB Health HBPC program
- Provides care to a patient not receiving in-home visits by a nurse practitioner.
- Is younger than 18 years of age
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 |
|---|---|---|
| CSNAT-IThe CSNAT intervention is a structured, caregiver-centered approach that identifies caregiver support needs and facilitates clinician-led support and problem-solving discussions. The intervention includes completion of the CSNAT assessment, collaborative care planning with a nurse practitioner, and a follow-up review of action plan implementation approximately one month later. Audio recordings may be collected, with participant consent, to assess intervention fidelity. | Behavioural | Behavioral: Carer Support Needs Assessment Tool (CSNAT) |
Primary outcome
Recruitment Feasibility
Time frame: During participant recruitment (up to 12 months).
Recruitment feasibility will be assessed by the time from identification of a potential participant to enrollment, participant refusal rate, and average time required to enroll 20 caregivers per study arm.
Participant Acceptability of CSNAT Intervention
Time frame: From posttest to two weeks following completion of the post-intervention assessment
Acceptability of the CSNAT intervention will be assessed through semi-structured qualitative interviews conducted with intervention participants who complete the study intervention. Interviews will explore: (1) caregiver experiences and caregiving-related stressors; (2) caregiver support needs; (3) participant experiences with and perceptions of the CSNAT intervention; and (4) barriers and facilitators to participation in the intervention. Interview data will be analyzed to identify themes related to the acceptability, perceived usefulness, and implementation of the intervention.
Participant Retention
Time frame: From enrollment through completion of post-intervention assessments (approximately 1 month).
Retention will be assessed as the proportion of enrolled participants who complete both baseline and post-intervention assessments.
Intervention Adherence
Time frame: From intervention initiation through completion of the one-month follow-up discussion.
Intervention adherence will be assessed as the proportion of participants in the intervention arm who complete the CSNAT assessment and both planned support discussions with the nurse practitioner.
6 secondary outcomes
Change from Baseline in Caregiving Strain at One Month
Time frame: Baseline and one month
Change From Baseline in Caregiver Physical Health at One Month
Time frame: Baseline and one month
Change From Baseline in Caregiver Quality of Life at One Month
Time frame: Baseline to one month
Change from Baseline in Elder Mistreatment and Neglect Scores and Associations with Other Secondary Measures at One Month
Time frame: Baseline and one month
Change From Baseline in Caregiver Mental Health at One Month
Time frame: Baseline to one month
Change From Baseline in Caregiver Depressive Symptoms at One Month
Time frame: Baseline to one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 15318762Naumann VJ, Byrne GJ. WHOQOL-BREF as a measure of quality of life in older patients with depression. Int Psychogeriatr. 2004 Jun;16(2):159-73. doi: 10.1017/s1041610204000109.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 24859223Ayalon L. Reports of Elder Neglect by Older Adults, Their Family Caregivers, and Their Home Care Workers: A Test of Measurement Invariance. J Gerontol B Psychol Sci Soc Sci. 2015 May;70(3):432-42. doi: 10.1093/geronb/gbu051. Epub 2014 May 23.
- Background: PubMed 15673349Beach SR, Schulz R, Williamson GM, Miller LS, Weiner MF, Lance CE. Risk factors for potentially harmful informal caregiver behavior. J Am Geriatr Soc. 2005 Feb;53(2):255-61. doi: 10.1111/j.1532-5415.2005.53111.x.
- Background: PubMed 16287207Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006 Jul;15(7):613-22. doi: 10.1002/pon.1001.
- Background: PubMed 26719349Grande GE, Austin L, Ewing G, O'Leary N, Roberts C. Assessing the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in palliative home care: a stepped wedge cluster trial. BMJ Support Palliat Care. 2017 Sep;7(3):326-334. doi: 10.1136/bmjspcare-2014-000829. Epub 2015 Dec 30.
- Background: PubMed 25849348Aoun SM, Grande G, Howting D, Deas K, Toye C, Troeung L, Stajduhar K, Ewing G. The impact of the carer support needs assessment tool (CSNAT) in community palliative care using a stepped wedge cluster trial. PLoS One. 2015 Apr 7;10(4):e0123012. doi: 10.1371/journal.pone.0123012. eCollection 2015.
- Individual participant dataSharing planned: No. Individual, de-identified participant data will be shared only with the study team and grant principal investigators for oversight purposes. No external sharing is planned.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSNAT-I in people with Caregiver Stress and Caregiver Health Related QOL, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen E. Schlag, PhD ((409)772-1011, keschlag@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: During participant recruitment (up to 12 months).). The study lists 4 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 NCT07749482, which also lists 7 linked publications.
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 2 Nov 2026.