Trial Outcomes & Findings for The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease (NCT NCT04555720)

NCT ID: NCT04555720

Last Updated: 2024-08-13

Results Overview

Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: Baseline, 3 months after interdisciplinary or standard clinic visit
• Results posted on: 2024-08-13

Participant Flow

Participant milestones

Measure	Interdisciplinary Care If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.	Interdisciplinary Care - Caregivers Caregivers for participants in the Interdisciplinary Care arm	Standard of Care - Caregivers Caregivers for participants in the standard of care arm
Overall Study STARTED	24	25	7	5
Overall Study COMPLETED	18	19	7	5
Overall Study NOT COMPLETED	6	6	0	0

Reasons for withdrawal

Measure	Interdisciplinary Care If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.	Interdisciplinary Care - Caregivers Caregivers for participants in the Interdisciplinary Care arm	Standard of Care - Caregivers Caregivers for participants in the standard of care arm
Overall Study Lost to Follow-up	2	0	0	0
Overall Study Withdrawal by Subject	4	6	0	0

Baseline Characteristics

Age of participants in the 2 Caregiver arms was not collected

Baseline characteristics by cohort

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.	Interdisciplinary Care - Caregivers Caregivers for participants in the Interdisciplinary Care arm	Standard of Care - Caregivers Caregivers for participants in the standard of care arm	Total n=37 Participants Total of all reporting groups
Age, Continuous	66.9 years STANDARD_DEVIATION 10.2 • n=5 Participants • Age of participants in the 2 Caregiver arms was not collected	62.5 years STANDARD_DEVIATION 10.4 • n=7 Participants • Age of participants in the 2 Caregiver arms was not collected	—	—	64.6 years STANDARD_DEVIATION 10.4 • n=21 Participants • Age of participants in the 2 Caregiver arms was not collected
Sex: Female, Male Female	6 Participants n=5 Participants • Sex was not collected for participants in the 2 Caregiver arms	7 Participants n=7 Participants • Sex was not collected for participants in the 2 Caregiver arms	0 Participants n=5 Participants • Sex was not collected for participants in the 2 Caregiver arms	0 Participants n=4 Participants • Sex was not collected for participants in the 2 Caregiver arms	13 Participants n=21 Participants • Sex was not collected for participants in the 2 Caregiver arms
Sex: Female, Male Male	12 Participants n=5 Participants • Sex was not collected for participants in the 2 Caregiver arms	12 Participants n=7 Participants • Sex was not collected for participants in the 2 Caregiver arms	0 Participants n=5 Participants • Sex was not collected for participants in the 2 Caregiver arms	0 Participants n=4 Participants • Sex was not collected for participants in the 2 Caregiver arms	24 Participants n=21 Participants • Sex was not collected for participants in the 2 Caregiver arms
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected	1 Participants n=7 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected	—	—	1 Participants n=21 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected	18 Participants n=7 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected	—	—	36 Participants n=21 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected	0 Participants n=7 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected	—	—	0 Participants n=21 Participants • Ethnicity of participants in the 2 Caregiver arms was not collected
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	0 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	0 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Race (NIH/OMB) Asian	0 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	1 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	1 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	0 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	0 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	3 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	3 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Race (NIH/OMB) White	18 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	15 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	33 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	0 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	0 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Race of participants in the 2 Caregiver Arms was not collected	0 Participants n=7 Participants • Race of participants in the 2 Caregiver Arms was not collected	—	—	0 Participants n=21 Participants • Race of participants in the 2 Caregiver Arms was not collected
Region of Enrollment United States	18 participants n=5 Participants	19 participants n=7 Participants	—	—	37 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months after interdisciplinary or standard clinic visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Title of scale: Self-efficacy Scale for Chronic Diseases. This is a validated scale. Minimum score is 6, Maximum score is 60. Higher score is a better outcome.

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Change in Composite Score on Self-efficacy Scale	38.5 score on a scale Interval 30.0 to 42.0	43 score on a scale Interval 38.0 to 49.0

SECONDARY outcome

Timeframe: Baseline, 3 months after interdisciplinary or standard care visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Investigator developed patient engagement survey

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.	138.3 minutes Standard Deviation 186.4	205.2 minutes Standard Deviation 147

SECONDARY outcome

Timeframe: Baseline, 3 months after interdisciplinary or standard care visit

Population: Only care partners were analyzed

Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.

Outcome measures

Measure	Interdisciplinary Care n=7 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=5 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Change in Caregiver Burden Score on Zarit Burden Interview Scale	8 score on a scale Interval 5.0 to 16.0	16 score on a scale Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: Baseline, 3 months after interdisciplinary or standard care visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Number of skilled therapy visits as reported by participant

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Number of Skilled Therapy Visits as Reported by Participant	3.5 visits Standard Deviation 8.5	9 visits Standard Deviation 23.1

SECONDARY outcome

Timeframe: Baseline, 3-6 months after interdisciplinary or standard care visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Number of participants with a hospitalization as reported by participant and medical record review

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review	1 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline, 3-6 months after interdisciplinary or standard care visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Number of participants with an ER visit as reported by participant and medical record review

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Number of Participants With an ER Visit as Reported by Participant and Medical Record Review	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline, 3 months after interdisciplinary or standard care visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Number participants with a fall as reported by Participant and Medical Record Review

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Number Participants With a Fall as Reported by Participant and Medical Record Review	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, 3-6 months after interdisciplinary or standard care visit

Population: Data was not collected for the "Interdisciplinary Care - Caregivers" and "Standard of Care - Caregivers" groups.

Number of participants with a contraindicated medication combination as determined by medical record review

Outcome measures

Measure	Interdisciplinary Care n=18 Participants If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participant's doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations. Interdisciplinary Visit: If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.	Standard of Care n=19 Participants If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review	0 Participants	0 Participants

Adverse Events

Interdisciplinary Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Kyle Mitchell, MD

Duke University Medical Center

Phone: 919-668-2879

Email: kyle.mitchell@duke.edu

Results disclosure agreements

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