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Trial Outcomes & Findings for CCCR Lupus Patient Navigator Program (NCT NCT04461158)

NCT ID: NCT04461158

Last Updated: 2025-05-04

Results Overview

Qualify of life measured by the "LupusPRO" patient-reported questionnaire administered at Baseline and 12 Months in the Intervention Group, resulting in a LupusPRO score. LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable. Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

12 months - from baseline to 12 month visit

Results posted on

2025-05-04

Participant Flow

Participant milestones

Participant milestones
Measure
Interventional Group
Patient Navigator Services: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support
Usual Care Comparison Group
Usual Care Comparison Group meeting eligibility criteria for intervention but not receiving Lupus Patient Navigator Program services.
Overall Study
STARTED
52
23
Overall Study
COMPLETED
46
23
Overall Study
NOT COMPLETED
6
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CCCR Lupus Patient Navigator Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Group
n=52 Participants
Receiving Lupus Patient Navigator Program services.
Usual Care Comparison Group
n=23 Participants
Usual Care Comparison Group meeting eligibility criteria for intervention but not receiving Lupus Patient Navigator Program services.
Total
n=75 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
52 Participants
n=5 Participants
23 Participants
n=7 Participants
75 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
34.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
34.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
34.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male
Female
50 Participants
n=5 Participants
18 Participants
n=7 Participants
68 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants
n=5 Participants
21 Participants
n=7 Participants
70 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
50 Participants
n=5 Participants
22 Participants
n=7 Participants
72 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
52 participants
n=5 Participants
23 participants
n=7 Participants
75 participants
n=5 Participants
Age at lupus onset
25.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
28.4 years
STANDARD_DEVIATION 10.3 • n=7 Participants
26.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months - from baseline to 12 month visit

Population: 52 patients with SLE self identified as a minority, met inclusion / exclusion criteria, and provided informed consent to participate with the Lupus Patient Navigator Program intervention.

Qualify of life measured by the "LupusPRO" patient-reported questionnaire administered at Baseline and 12 Months in the Intervention Group, resulting in a LupusPRO score. LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable. Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses

Outcome measures

Outcome measures
Measure
Interventional Group
n=52 Participants
Patient Navigator Services: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support
Improvement in Quality of Life
Baseline Health-related QOL
59.2 score on a scale
Standard Deviation 20.6
Improvement in Quality of Life
12 Month Health-related QOL
63.6 score on a scale
Standard Deviation 22.1

SECONDARY outcome

Timeframe: 12 months - from baseline to 12 month visit

Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between Lupus Patient Navigator Program (LPNP) participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months - from baseline to 12 month visit

Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months - from baseline to 12 month visit

Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients.

Outcome measures

Outcome data not reported

Adverse Events

Interventional Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual Care Comparison 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

Dr. Jim C. Oates, MD, Rheumatology Division Director

Medical University of South Carolina

Phone: 843-792-1991

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place