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Understanding Needs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118609
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Arlene Schmid, Colorado State University

Study Description
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Brief 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. 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


Condition or disease Intervention/treatment Phase
Caregivers Other: Understanding Needs Survey Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

A single focus group.

A single group will be analyzed based on survey results
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Understanding the Needs of Informal Caregivers
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : January 16, 2019
Actual Study Completion Date : January 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arms and Interventions
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Arm Intervention/treatment
Experimental: Caregivers for "Understanding Needs"

5-8 informal caregiver participants in focus group will discuss current perceived needs.

Up to 150 participants will complete the "Understanding Needs" survey

 Other: Understanding Needs Survey

2-hour Focus Group

Mailed or E-mailed Survey


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118609


Locations
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United States, Colorado
Colorado State University
Fort Collins, Colorado, United States, 80524
Sponsors and Collaborators
Colorado State University
More Information
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Responsible Party: Arlene Schmid, Prinicipal Investigator, Colorado State University
ClinicalTrials.gov Identifier: NCT03118609    
Other Study ID Numbers: 16-6969H
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arlene Schmid, Colorado State University:
Caregivers
Chronic Pain