Trial Outcomes & Findings for Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial (NCT NCT06182423)
NCT ID: NCT06182423
Last Updated: 2026-05-22
Results Overview
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing a worse outcome. Change score represents \[follow-up score - baseline score\].
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline, 10 weeks from baseline
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
STEPS-CI Intervention Group
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version): This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
|
STEPS-CI Control Group
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
23
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing sex information for one participant.
Baseline characteristics by cohort
| Measure |
STEPS-CI Intervention Group
n=28 Participants
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version): This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
|
STEPS-CI Control Group
n=29 Participants
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 12.0 • n=28 Participants
|
66.8 years
STANDARD_DEVIATION 10.4 • n=29 Participants
|
67.5 years
STANDARD_DEVIATION 11.1 • n=57 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=27 Participants • Missing sex information for one participant.
|
23 Participants
n=29 Participants • Missing sex information for one participant.
|
45 Participants
n=56 Participants • Missing sex information for one participant.
|
|
Sex: Female, Male
Male
|
5 Participants
n=27 Participants • Missing sex information for one participant.
|
6 Participants
n=29 Participants • Missing sex information for one participant.
|
11 Participants
n=56 Participants • Missing sex information for one participant.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=28 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=28 Participants
|
28 Participants
n=29 Participants
|
54 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=57 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=28 Participants
|
11 Participants
n=29 Participants
|
21 Participants
n=57 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=28 Participants
|
15 Participants
n=29 Participants
|
28 Participants
n=57 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=28 Participants
|
2 Participants
n=29 Participants
|
4 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
3 Participants
n=57 Participants
|
|
Pain Interference
|
60.6 score on a scale
STANDARD_DEVIATION 8.4 • n=28 Participants
|
61.3 score on a scale
STANDARD_DEVIATION 6.6 • n=29 Participants
|
60.9 score on a scale
STANDARD_DEVIATION 7.5 • n=57 Participants
|
|
Pain intensity
|
5.6 score on a scale
STANDARD_DEVIATION 2.0 • n=28 Participants
|
6.2 score on a scale
STANDARD_DEVIATION 1.9 • n=29 Participants
|
5.9 score on a scale
STANDARD_DEVIATION 2.0 • n=57 Participants
|
|
Subjective cognitive functioning
|
46.0 units on a scale
STANDARD_DEVIATION 7.8 • n=27 Participants • One participant in the intervention group had missing data.
|
43.6 units on a scale
STANDARD_DEVIATION 6.6 • n=29 Participants • One participant in the intervention group had missing data.
|
44.7 units on a scale
STANDARD_DEVIATION 7.2 • n=56 Participants • One participant in the intervention group had missing data.
|
PRIMARY outcome
Timeframe: Baseline, 10 weeks from baselinePopulation: All participants who were assigned to the control or intervention group
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing a worse outcome. Change score represents \[follow-up score - baseline score\].
Outcome measures
| Measure |
STEPS-CI Intervention Group
n=28 Participants
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version): This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
|
STEPS-CI Control Group
n=29 Participants
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
|
|---|---|---|
|
Change in Pain Interference
|
-0.9 units on a scale
Standard Deviation 5.5
|
0.2 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 10 weeks from baselinePopulation: All participants who were assigned to the control or intervention group.
A numeric rating scale of pain in the last week ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome). Change score represents \[follow-up score - baseline score\].
Outcome measures
| Measure |
STEPS-CI Intervention Group
n=28 Participants
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version): This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
|
STEPS-CI Control Group
n=29 Participants
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
|
|---|---|---|
|
Change in Pain Intensity
|
-0.1 score on a scale
Standard Deviation 2.3
|
-0.2 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, 10 weeks from baselinePopulation: One participant in intervention group had missing data on this measure.
The 4-item PROMIS Cognitive Function-Abilities Short Form 4a V. 2.0 measures perceived cognitive functioning in the last 4 days (e.g., "My mind has been as sharp as usual") on a scale from 1=not at all to 5=very much. Scores are converted to a standardized T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means better cognitive functioning. Change score represents \[follow-up score - baseline score\].
Outcome measures
| Measure |
STEPS-CI Intervention Group
n=27 Participants
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version): This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
|
STEPS-CI Control Group
n=29 Participants
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
|
|---|---|---|
|
Change in Subjective Cognitive Functioning
|
1.2 score on a scale
Standard Deviation 3.9
|
1.9 score on a scale
Standard Deviation 7.5
|
Adverse Events
STEPS-CI Intervention Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
STEPS-CI Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STEPS-CI Intervention Group
n=28 participants at risk
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version): This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
|
STEPS-CI Control Group
n=29 participants at risk
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
|
|---|---|---|
|
General disorders
Hospitalization
|
3.6%
1/28 • 10 weeks
|
0.00%
0/29 • 10 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place