Trial Outcomes & Findings for Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving. (NCT NCT05847881)

Last Updated: 2024-10-23

Results Overview

The timepoints were as follows: consent and survey (T1), Kick-off Meeting (T2), Workshop (T3), and Exit Interview (T4). Participants had to attend the Kick-off Meeting (T2) to be considered engaged in the intervention. Participants who did not attend the Kick-off Meeting (T2) were withdrawn. Participants who did not attend the Workshop (T3) could still attend the Exit Interview (T4).

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Baseline (T1) to Exit Interview (T4), up to 68 days

Results posted on

2024-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Reflective Process Group Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Overall Study STARTED	23
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Reflective Process Group Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Overall Study Principal Investigator Decision	8
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reflective Process Group n=23 Participants Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Region of Enrollment United States	23 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline (T1) to Exit Interview (T4), up to 68 days

Outcome measures

Outcome measures
Measure	Reflective Process Group n=23 Participants Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Participants Engaged in the Interventions Consent and Survey (T1)	23 Participants
Participants Engaged in the Interventions Kick off Meeting (T2)	14 Participants
Participants Engaged in the Interventions Workshop (T3)	12 Participants
Participants Engaged in the Interventions Exit Interview	13 Participants

SECONDARY outcome

Timeframe: at T4 Exit Interview, up to 68 days

Population: Results reflect the participants who attended the T4 exit interview and completed the PGIC. Of the 13 participants who attended the exit interview, 1 did not complete the PGIC.

Participants completed the PGIC at the exit interview. The PGIC had one question with seven options ranging from -3 to 3: very much worse (-3), much worse (-2), minimally worse (-1), no change (0), minimally improved (1), much improved (2), very much improved (3). A higher score indicated greater improvement since the start of the study.

Outcome measures

Outcome measures
Measure	Reflective Process Group n=12 Participants Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Patient Global Impression of Change (PGIC) at T4 Exit Interview Very much improved	0 Participants
Patient Global Impression of Change (PGIC) at T4 Exit Interview Much Improved	4 Participants
Patient Global Impression of Change (PGIC) at T4 Exit Interview Minimally Improved	5 Participants
Patient Global Impression of Change (PGIC) at T4 Exit Interview No change	2 Participants
Patient Global Impression of Change (PGIC) at T4 Exit Interview Minimally worse	0 Participants
Patient Global Impression of Change (PGIC) at T4 Exit Interview Much worse	1 Participants
Patient Global Impression of Change (PGIC) at T4 Exit Interview Very much worse	0 Participants

SECONDARY outcome

Timeframe: Up to 68 days

Population: The difference between the number of participants at baseline and in the results here is because of participant attrition and incomplete responses from participants that could not be included in the final results data.

There were 4 questions in this questionnaire. For each question, participants selected one of five options, ranging from "not at all" (1) to "very much" (5). Total scores ranged from 4 to 20 points, where higher scores indicated more pain interference. Since this survey was discussing the change in the pain interference, a negative score indicated less pain interfering with day-to-day activities.The change betwen the baseline (T1 and Exit Interview (t4) is reported.

Outcome measures

Outcome measures
Measure	Reflective Process Group n=23 Participants Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview) Baseline	13.833 score on a scale Standard Deviation 2.791
Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview) Change from Baseline to Exit Interview	-1.583 score on a scale Standard Deviation 3.753

Adverse Events

Reflective Process Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Afton L. Hassett, PsyD

Back & Pain Center Clinical Research

Phone: 734-763-5226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place