CaregiversNCT03118609
Understanding Needs
A study testing Understanding Needs Survey in people with Caregivers, run by Colorado State University at 1 site in United States.
Trial summary
The "Understanding Needs" Project is designed to gain an understanding of the needs of informal caregivers. Researchers have designed a survey to highlight activities of daily living involved in the caregiving role, pain related to caregiver, and potential services desired. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- Understanding Needs Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 16 Jan 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Informal caregivers (unpaid)
- have been a caregiver for > 6 months
- provide at least 8 hours of care/week
- able to read english
Who cannot join
- Less than 18 years old
- paid caregivers
- not able to read english
- Caregiver or care recipient has a terminal diagnosis with a life expectancy of less than one year
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80524
About this study
Official title: Understanding the Needs of Informal Caregivers
The "Understanding Needs" Project is designed to gain an understanding of the needs of informal caregivers. Researchers have designed a survey to highlight activities of daily living involved in the caregiving role, pain related to caregiver, and potential services desired. The initial phase of the study will consist of a focus group of informal caregivers to discuss current needs. The survey will then be refined based on knowledge gained from the focus group, and feedback from expert researchers. The refined survey will then be disseminated to caregivers throughout the country.
Please click on the following anonymous link to participate: https://chhscolostate.co1.qualtrics.com/jfe/form/SV_54j83BQSItMuoUB
Read the detailed description
The "Understanding Needs" Project highlights the needs of informal caregivers. An informal caregiver is defined as a person who regularly provides unpaid care to another adult. The survey will ask about pain intensity, pain interference, and relation of pain to the caregiving role. The survey will also address which activities the caregiver assists with, and activities now lacking since becoming a caregiver. One focus group will be completed to refine the contents of the survey prior to dissemination. The results will be analyzed by an occupational therapist, with a focus on how pain may connect to assistance with daily living activities provided to the care recipient. The needs of caregivers within the community will be compiled to inform future involvement in remediation of needs.
- Conditions
- Caregivers
- Being tested
- Understanding Needs Survey
- Keywords
- Caregivers, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Understanding Needs SurveyOther
2-hour Focus Group
Mailed or E-mailed Survey
| Study group | Role | What they receive |
|---|---|---|
| Caregivers for "Understanding Needs" | Experimental | 5-8 informal caregiver participants in focus group will discuss current perceived needs.
Up to 150 participants will complete the "Understanding Needs" survey Receives: Other: Understanding Needs Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEG: Three Item Pain Measure
A self-rating of pain intensity, pain interference in enjoyment of life, and pain interference in general activity
Measured: Self-report, up to one year for analyses when all surveys are returned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start12 Apr 2017
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single focus group. A single group will be analyzed based on survey results
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlene Schmid, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118609
- Sponsor's protocol ID
- 16-6969H
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Needs of Informal Caregivers
- ClinicalTrials.gov ID
- NCT03118609
- Acronym / sponsor ID
- 16-6969H
- Conditions
- Caregivers
- Keywords
- Caregivers, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 18 Apr 2017 (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.
The "Understanding Needs" Project is designed to gain an understanding of the needs of informal caregivers. Researchers have designed a survey to highlight activities of daily living involved in the caregiving role, pain related to caregiver, and potential services desired. The initial phase of the study will consist of a focus group of informal caregivers to discuss current needs. The survey will then be refined based on knowledge gained from the focus group, and feedback from expert researchers. The refined survey will then be disseminated to caregivers throughout the country.
Please click on the following anonymous link to participate: https://chhscolostate.co1.qualtrics.com/jfe/form/SV_54j83BQSItMuoUB
Detailed description
The "Understanding Needs" Project highlights the needs of informal caregivers. An informal caregiver is defined as a person who regularly provides unpaid care to another adult. The survey will ask about pain intensity, pain interference, and relation of pain to the caregiving role. The survey will also address which activities the caregiver assists with, and activities now lacking since becoming a caregiver. One focus group will be completed to refine the contents of the survey prior to dissemination. The results will be analyzed by an occupational therapist, with a focus on how pain may connect to assistance with daily living activities provided to the care recipient. The needs of caregivers within the community will be compiled to inform future involvement in remediation of needs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single focus group. A single group will be analyzed based on survey results
| Arm | Type | Receives |
|---|---|---|
| Caregivers for "Understanding Needs" | Experimental | Other: Understanding Needs Survey5-8 informal caregiver participants in focus group will discuss current perceived needs. Up to 150 participants will complete the "Understanding Needs" survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Informal caregivers (unpaid)
- have been a caregiver for > 6 months
- provide at least 8 hours of care/week
- able to read english
Key exclusion criteria (4 listed)
- Less than 18 years old
- paid caregivers
- not able to read english
- Caregiver or care recipient has a terminal diagnosis with a life expectancy of less than one year
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 |
|---|---|---|
| Understanding Needs Survey2-hour Focus Group Mailed or E-mailed Survey | Other | Caregivers for "Understanding Needs" |
Primary outcome
PEG: Three Item Pain Measure
Time frame: Self-report, up to one year for analyses when all surveys are returned
A self-rating of pain intensity, pain interference in enjoyment of life, and pain interference in general activity
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 23 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Understanding Needs Survey in people with Caregivers, run by Colorado State University 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 4 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 23 Jul 2019. 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?
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?
PEG: Three Item Pain Measure (time frame: Self-report, up to one year for analyses when all surveys are returned). 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 23 Jul 2019.