University of Colorado Anschutz
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Erika Shelton
CONTACT
3037244644 ext. Fullard
Michelle E Fullard
CONTACT
Michelle E Fullard, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06446505
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
Erika Shelton
CONTACT
3037244644 ext. Fullard
Michelle E Fullard
CONTACT
Michelle E Fullard, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.
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.
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.
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.
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.
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.
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.
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
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.
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
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.
Time frame: Baseline
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".
Time frame: 3 Months
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".
Time frame: 2 weeks after decision for deep brain stimulation surgery
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".
Time frame: Baseline
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".
Time frame: 1 Month
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".
Time frame: 3 Months
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".
Time frame: 2 weeks after decision for deep brain stimulation surgery
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".
Time frame: 2 weeks after decision for deep brain stimulation surgery
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.
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
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.
Time frame: Baseline
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
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.
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
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.
Time frame: Baseline
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 1 Month
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 3 Months
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 1 Month
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).
Time frame: 3 Months
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).
Time frame: 2 weeks after decision for deep brain stimulation surgery
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).
Time frame: 2 weeks after decision for deep brain stimulation surgery
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.
Contact information is provided by the study sponsor or research team.
Erika Shelton
CONTACT
Michelle E Fullard, MD
CONTACT
University of Colorado, Denver
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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