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Compass Course: COVID-19 (CC-COVID)

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compass Course
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring Purpose in Life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 80 years of age;
  • Are part of the AH COVID Research Registry or are receiving/have received therapy services for COVID-19 related sequelae at CKRI;
  • English speaking
  • Graduated from high school
  • Able to see, hear, speak (with or without assistive devices)
  • Access to computer or tablet and adequate internet connection to participate in video conference
  • Has an email address;
  • Own a smartphone with one of the following operating system versions:

iOS 9.0 - 9.3, 10.0 - 10.3, 12, 13.3, 13.7, 14.0 - 14.4 or later Android 8.0 - 8.1.0, 9, 10, 11 or later

  • Agree to use personal smartphone to download mEMA application and respond to application notifications (mEMA is described in Sections 3.2.3.1 and 3.2.4.2.2);
  • Willing and able to commit to attend all intervention sessions

Exclusion Criteria:

  • History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning;
  • Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

Sites / Locations

  • Abbott Northwestern Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compass Course

Arm Description

Four groups of up to 12 participants (48 total) will receive the study intervention during Spring and Fall 2022. All participants will complete study questionnaires before and after the sessions.

Outcomes

Primary Outcome Measures

Change in Psychological Wellbeing
Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.

Secondary Outcome Measures

Change in Meaning in Life Questionnaire
Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
Change in Purpose Status Question
Purpose Status Question (PSQ) is a one-item questionnaire designed by the study team to measure participants' current purpose status

Full Information

First Posted
March 23, 2022
Last Updated
March 27, 2023
Sponsor
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05295238
Brief Title
Compass Course: COVID-19
Acronym
CC-COVID
Official Title
Purpose in Life Renewal for Adults Who Experienced COVID-19 Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allina Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A group of clinicians and researchers developed an 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives. Participating in this research will involve an introduction session, where informed consent will be obtained, followed by the 8-session intervention for 9 sessions in total. A team composed of researchers from Courage Kenny Rehabilitation Institute (CKRI) propose to recruit a convenience sample of individuals who were hospitalized with COVID-19 to evaluate the efficacy of administering the Compass Course to a novel population, to improve psychological well-being, engagement in everyday activities, and purpose in life. A focus group will be scheduled 2 months after the completion of the Compass Course. This session is composed of brief questionnaires and designed to obtain post-course data to help evaluate the Compass Course intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Purpose in Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compass Course
Arm Type
Experimental
Arm Description
Four groups of up to 12 participants (48 total) will receive the study intervention during Spring and Fall 2022. All participants will complete study questionnaires before and after the sessions.
Intervention Type
Behavioral
Intervention Name(s)
Compass Course
Intervention Description
An 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives.
Primary Outcome Measure Information:
Title
Change in Psychological Wellbeing
Description
Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.
Time Frame
Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Secondary Outcome Measure Information:
Title
Change in Meaning in Life Questionnaire
Description
Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
Time Frame
Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Title
Change in Purpose Status Question
Description
Purpose Status Question (PSQ) is a one-item questionnaire designed by the study team to measure participants' current purpose status
Time Frame
Will be assessed at baseline (week 0) and completion (following session 8, week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 80 years of age; Are part of the Allina Health COVID Research Registry or are receiving/have received therapy services for COVID-19 related sequelae at CKRI; English speaking Graduated from high school Able to see, hear, speak (with or without assistive devices) Access to computer or tablet and adequate internet connection to participate in video conference Has an email address; Own a smartphone with one of the following operating system versions: iOS 9.0 - 9.3, 10.0 - 10.3, 12, 13.3, 13.7, 14.0 - 14.4 or later Android 8.0 - 8.1.0, 9, 10, 11 or later Agree to use personal smartphone to download mEMA application and respond to application notifications (mEMA is described in Sections 3.2.3.1 and 3.2.4.2.2); Willing and able to commit to attend all intervention sessions Exclusion Criteria: History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning; Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary V Radomski, OTR/L, PhD
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55447
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be made available.

Learn more about this trial

Compass Course: COVID-19

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