Parkinson Disease
Conditions
Keywords
interdisciplinary care, patient engagement, preventative care
Brief summary
The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room. Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care. This study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care.
Interventions
BEHAVIORALInterdisciplinary 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Parkinson's Disease over the age of 30, * Caregiver willing to also participate. * Must be able to provide consent.
Exclusion criteria
-Atypical Parkinsonism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Score on Self-efficacy Scale | Baseline, 3 months after interdisciplinary or standard clinic visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Burden Score on Zarit Burden Interview Scale | Baseline, 3 months after interdisciplinary or standard care visit | Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome. |
| Number of Skilled Therapy Visits as Reported by Participant | Baseline, 3 months after interdisciplinary or standard care visit | Number of skilled therapy visits as reported by participant |
| Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review | Baseline, 3-6 months after interdisciplinary or standard care visit | Number of participants with a hospitalization as reported by participant and medical record review |
| Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey. | Baseline, 3 months after interdisciplinary or standard care visit | Investigator developed patient engagement survey |
| Number Participants With a Fall as Reported by Participant and Medical Record Review | Baseline, 3 months after interdisciplinary or standard care visit | Number participants with a fall as reported by Participant and Medical Record Review |
| Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review | Baseline, 3-6 months after interdisciplinary or standard care visit | Number of participants with a contraindicated medication combination as determined by medical record review |
| Number of Participants With an ER Visit as Reported by Participant and Medical Record Review | Baseline, 3-6 months after interdisciplinary or standard care visit | Number of participants with an ER visit as reported by participant and medical record review |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Standard of Care If assigned to standard of care, group participants will have a normally scheduled visit with neurologist. | 19 |
| Interdisciplinary Care - Caregivers Caregivers for participants in the Interdisciplinary Care arm | 0 |
| Standard of Care - Caregivers Caregivers for participants in the standard of care arm | 0 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 0 | 0 |
Baseline characteristics
| Characteristic | Interdisciplinary Care | Standard of Care | Total | Standard of Care - Caregivers | Interdisciplinary Care - Caregivers |
|---|---|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 10.2 | 62.5 years STANDARD_DEVIATION 10.4 | 64.6 years STANDARD_DEVIATION 10.4 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | — | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants | 36 Participants | — | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | — | — |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) White | 18 Participants | 15 Participants | 33 Participants | — | — |
| Region of Enrollment United States | 18 participants | 19 participants | 37 participants | — | — |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 |
| other Total, other adverse events | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Change in Composite Score on Self-efficacy Scale
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interdisciplinary Care | Change in Composite Score on Self-efficacy Scale | 38.5 score on a scale |
| Standard of Care | Change in Composite Score on Self-efficacy Scale | 43 score on a scale |
Secondary
Change in Caregiver Burden Score on Zarit Burden Interview Scale
Title of scale: Zarit Burden Interview. This is validated scale. Minimum score is 0. Maximum score is 88. Higher score is a worse outcome.
Time frame: Baseline, 3 months after interdisciplinary or standard care visit
Population: Only care partners were analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interdisciplinary Care | Change in Caregiver Burden Score on Zarit Burden Interview Scale | 8 score on a scale |
| Standard of Care | Change in Caregiver Burden Score on Zarit Burden Interview Scale | 16 score on a scale |
Secondary
Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey.
Investigator developed patient engagement survey
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interdisciplinary Care | Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey. | 138.3 minutes | Standard Deviation 186.4 |
| Standard of Care | Change in Total Weekly Minutes Exercised as Measured by Patient Engagement Survey. | 205.2 minutes | Standard Deviation 147 |
Secondary
Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review
Number of participants with a contraindicated medication combination as determined by medical record review
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interdisciplinary Care | Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review | 0 Participants |
| Standard of Care | Number of Participants With a Contraindicated Medication Combination as Determined by Medical Record Review | 0 Participants |
Secondary
Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review
Number of participants with a hospitalization as reported by participant and medical record review
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interdisciplinary Care | Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review | 1 Participants |
| Standard of Care | Number of Participants With a Hospitalization as Reported by Participant and Medical Record Review | 8 Participants |
Secondary
Number of Participants With an ER Visit as Reported by Participant and Medical Record Review
Number of participants with an ER visit as reported by participant and medical record review
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interdisciplinary Care | Number of Participants With an ER Visit as Reported by Participant and Medical Record Review | 5 Participants |
| Standard of Care | Number of Participants With an ER Visit as Reported by Participant and Medical Record Review | 11 Participants |
Secondary
Number of Skilled Therapy Visits as Reported by Participant
Number of skilled therapy visits as reported by participant
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interdisciplinary Care | Number of Skilled Therapy Visits as Reported by Participant | 3.5 visits | Standard Deviation 8.5 |
| Standard of Care | Number of Skilled Therapy Visits as Reported by Participant | 9 visits | Standard Deviation 23.1 |
Secondary
Number Participants With a Fall as Reported by Participant and Medical Record Review
Number participants with a fall as reported by Participant and Medical Record Review
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interdisciplinary Care | Number Participants With a Fall as Reported by Participant and Medical Record Review | 3 Participants |
| Standard of Care | Number Participants With a Fall as Reported by Participant and Medical Record Review | 2 Participants |