Parkinson DiseaseNCT06446505
Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
A study testing Deep Brain Stimulation Decision Aid in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are: Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep Brain Stimulation Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado
Who cannot join
- Atypical Parkinsonism
- Diagnosis of Dementia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Michelle E Fullard, 303-724-2194, michelle.fullard@cuanschutz.edu
Erika Shelton, 3037244644 ext. Fullard, erika.shelton@cuanschutz.edu
About this study
Official title: Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial
The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:
- Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?
- Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?
Read more
Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.
Participants will:
- Receive the decision aid at the beginning of the evaluation process or towards the end
- Complete surveys at 5 visits (remote or in-person) over approximately 6 months
- Conditions
- Parkinson Disease
- Being tested
- Deep Brain Stimulation Decision Aid
- Keywords
- Deep Brain Stimulation, Decision Aid
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation Decision AidOther
An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.
| Study group | Role | What they receive |
|---|---|---|
| Early Decision Aid | Experimental | Participants will receive the Decision Aid at baseline. Receives: Other: Deep Brain Stimulation Decision Aid |
| Delayed Decision Aid | Active comparator | Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process. Receives: Other: Deep Brain Stimulation Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability tool from the Ottawa Hospital Research Institute
This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
Measured: Baseline
Acceptability tool from the Ottawa Hospital Research Institute
This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
Measured: 2 weeks after decision for deep brain stimulation surgery
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Measured: Baseline
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Measured: 1 Month
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Measured: 3 Months
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Measured: 2 weeks after decision for deep brain stimulation surgery
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Measured: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Secondary outcomes (22)
Decision Quality Worksheet
The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS.
Measured: 2 weeks after decision for deep brain stimulation surgery
Decision Quality Worksheet
The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS.
Measured: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Decision Self-Efficacy scale
This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".
Measured: Baseline
Decision Self-Efficacy scale
This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".
Measured: 3 Months
Decision Self-Efficacy scale
This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".
Measured: 2 weeks after decision for deep brain stimulation surgery
Decision Readiness Instrument
This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
Measured: Baseline
Decision Readiness Instrument
This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
Measured: 1 Month
Decision Readiness Instrument
This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
Measured: 3 Months
Decision Readiness Instrument
This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
Measured: 2 weeks after decision for deep brain stimulation surgery
Satisfaction with Decision Scale
This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision.
Measured: 2 weeks after decision for deep brain stimulation surgery
Satisfaction with Decision Scale
This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision.
Measured: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life.
Measured: Baseline
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life.
Measured: 2 weeks after decision for deep brain stimulation surgery
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life.
Measured: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Measured: Baseline
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Measured: 1 Month
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Measured: 3 Months
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Measured: 2 weeks after decision for deep brain stimulation surgery
Shared Decision-Making Questionnaire - 9
This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).
Measured: 1 Month
Shared Decision-Making Questionnaire - 9
This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).
Measured: 3 Months
Shared Decision-Making Questionnaire - 9
This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).
Measured: 2 weeks after decision for deep brain stimulation surgery
Trust in the Surgeon Scale
This scale measures how much the participant trusts their surgeon. The scale ranges from 11 to 55, with higher scores indicating a higher level of trust.
Measured: 2 weeks after decision for deep brain stimulation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Michelle E Fullard, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446505
- Sponsor's protocol ID
- 23-2390
- Other IDs
- K12AR084226
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share the de-identified dataset after the primary results have been accepted for publication. No patient identifiers will be included in the shared data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT06446505
- Acronym / sponsor ID
- 23-2390
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, Decision Aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:
- Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?
- Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?
Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.
Participants will:
- Receive the decision aid at the beginning of the evaluation process or towards the end
- Complete surveys at 5 visits (remote or in-person) over approximately 6 months
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Decision Aid | Experimental | Other: Deep Brain Stimulation Decision AidParticipants will receive the Decision Aid at baseline. |
| Delayed Decision Aid | Active comparator | Other: Deep Brain Stimulation Decision AidParticipants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado
Key exclusion criteria (2 listed)
- Atypical Parkinsonism
- Diagnosis of Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation Decision AidAn online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise. | Other | Delayed Decision Aid, Early Decision Aid |
Primary outcome
Acceptability tool from the Ottawa Hospital Research Institute
Time frame: Baseline
This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
Acceptability tool from the Ottawa Hospital Research Institute
Time frame: 2 weeks after decision for deep brain stimulation surgery
This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
Decisional Conflict Scale (DCS)
Time frame: Baseline
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Decisional Conflict Scale (DCS)
Time frame: 1 Month
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Decisional Conflict Scale (DCS)
Time frame: 3 Months
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Decisional Conflict Scale (DCS)
Time frame: 2 weeks after decision for deep brain stimulation surgery
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
Decisional Conflict Scale (DCS)
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
22 secondary outcomes
Decision Quality Worksheet
Time frame: 2 weeks after decision for deep brain stimulation surgery
Decision Quality Worksheet
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Decision Self-Efficacy scale
Time frame: Baseline
Decision Self-Efficacy scale
Time frame: 3 Months
Decision Self-Efficacy scale
Time frame: 2 weeks after decision for deep brain stimulation surgery
Decision Readiness Instrument
Time frame: Baseline
Decision Readiness Instrument
Time frame: 1 Month
Decision Readiness Instrument
Time frame: 3 Months
Decision Readiness Instrument
Time frame: 2 weeks after decision for deep brain stimulation surgery
Satisfaction with Decision Scale
Time frame: 2 weeks after decision for deep brain stimulation surgery
Satisfaction with Decision Scale
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
Time frame: Baseline
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
Time frame: 2 weeks after decision for deep brain stimulation surgery
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Expectations
Time frame: Baseline
Expectations
Time frame: 1 Month
Expectations
Time frame: 3 Months
Expectations
Time frame: 2 weeks after decision for deep brain stimulation surgery
Shared Decision-Making Questionnaire - 9
Time frame: 1 Month
Shared Decision-Making Questionnaire - 9
Time frame: 3 Months
Shared Decision-Making Questionnaire - 9
Time frame: 2 weeks after decision for deep brain stimulation surgery
Trust in the Surgeon Scale
Time frame: 2 weeks after decision for deep brain stimulation surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No. We plan to share the de-identified dataset after the primary results have been accepted for publication. No patient identifiers will be included in the shared data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle E Fullard, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation Decision Aid in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle E Fullard, MD (3037242194, michelle.fullard@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability tool from the Ottawa Hospital Research Institute (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.