N/A
N=539
Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
High Cholesterol · High Blood Pressure · Colorectal Cancer · Breast Cancer · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04317690 ↗Enrolled (actual)
539
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Shared Decision Making Process Measure — 2.12; 2.65; 1.61; 1.4 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Shared Decision Making Process Measure |
2.12; 2.65; 1.61; 1.4; 1.87 | — |
| SECONDARY Decisional Conflict Tool (SURE) |
68; 70; 68; 78; 71 | — |
| SECONDARY Decision Regret Scale |
22; 27; 17; 16; 25 | — |
| SECONDARY Single-Item Measure of Decision Regret |
49; 52; 77; 61; 50; 44 | — |
| SECONDARY Treatment Choice |
37; 64; 123; 72; 71; 61 | — |
| SECONDARY Adapted Controlled Preference Scale |
43; 46; 59; 49; 68; 18 | — |
| SECONDARY Shared Decision Making Process Measure Retest |
2.27; 2.32; 1.68; 1.57; 1.67 | — |
| SECONDARY Knowledge |
61; 56; 40; 43 | — |
Summary
The purpose of this study is to survey a sample of adults who have recently made a decision about treatment of high cholesterol or high blood pressure or a decision about screening for colorectal cancer, breast cancer, or prostate cancer. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions for these common medical situations.
Eligibility Criteria
Inclusion Criteria
High Blood Pressure Group
- Between the ages of 30-75
- No previous heart attack or stroke
- Have been diagnosed with high blood pressure
- Taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years
High Cholesterol
- Between the ages of 30-75
- No previous heart attack or stroke
- Have been diagnosed with high cholesterol
- Taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years
Colorectal Cancer Screening
- Between the ages of 50-75
- No previous diagnosis of colon cancer
- Have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years
- Had first colon cancer screening in past 2 years
Breast Cancer Screening
- Female
- Between the ages of 40-55
- No previous diagnosis of breast cancer
- Have had mammogram (or discussed having a mammogram) in the past 2 years
- Had first mammogram in past 2 years
Prostate Cancer Screening
- Male
- Between the ages of 45-69
- No previous diagnosis of prostate cancer
- Have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years
- Had first prostate cancer screening in past 2 years
Exclusion Criteria
High Blood Pressure Group
- None
High Cholesterol
- None
Colorectal Cancer Screening
- None
Breast Cancer Screening
- None
Prostate Cancer Screening
- None
Data sourced from ClinicalTrials.gov (NCT04317690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.