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| ID | Type | Description | Link |
|---|---|---|---|
| K12AR084226 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Decision Aid | Experimental | Participants will receive the Decision Aid at baseline. |
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| Delayed Decision Aid | Active Comparator | Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation Decision Aid | Other | An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks after decision for deep brain stimulation surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle E Fullard, MD | Contact | 3037242194 | michelle.fullard@cuanschutz.edu | |
| Erika Shelton | Contact | 3037244644 | erika.shelton@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle E Fullard, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Recruiting | Aurora | Colorado | 80045 | United States |
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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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | 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. | 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo 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. | 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". | 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". | 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". | 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". | 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". | 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". | 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". | 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. | 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. | 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. | 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. | 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. | 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. | Baseline |
| Expectations | Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery. | 1 Month |
| Expectations | Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery. | 3 Months |
| Expectations | Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery. | 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). | 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). | 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). | 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. | 2 weeks after decision for deep brain stimulation surgery |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |