NCT03118609

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 20, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

March 20, 2017

Last Update Submit

July 22, 2019

Conditions

Keywords

CaregiversChronic Pain

Outcome Measures

Primary Outcomes (1)

  • PEG: Three Item Pain Measure

    A self-rating of pain intensity, pain interference in enjoyment of life, and pain interference in general activity

    Self-report, up to one year for analyses when all surveys are returned

Study Arms (1)

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

Other: Understanding Needs Survey

Interventions

2-hour Focus Group Mailed or E-mailed Survey

Caregivers for "Understanding Needs"

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80524, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A single focus group. A single group will be analyzed based on survey results
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 18, 2017

Study Start

April 12, 2017

Primary Completion

January 16, 2019

Study Completion

January 16, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations