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| ID | Type | Description | Link |
|---|---|---|---|
| 26RIRA1635044 | Other Grant/Funding Number | American Heart Association |
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The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.
The investigators proposed a novel team-based shared decision-making (SDM) program. The overall goal of this proposal is to conduct a pilot randomized controlled trial to evaluate the SDM intervention compared to usual care among 94 adult patients with cardiometabolic factors and cardiovascular-kidney-metabolic (CKM) syndrome at a primary care clinic in Maryland. Participants in the intervention group will receive the 6-month intervention and usual care, while those in the control group will receive usual care. Specific aims include:
Aim 1: To evaluate the feasibility of the Team-Based SDM Program. Feasibility outcomes include recruitment, retention, intervention adherence, and fidelity.
Aim 2: To assess the preliminary efficacy of the Team-Based SDM Program versus usual care in improving clinical, patient-reported, and patient-centered outcomes at 12 weeks post-intervention
Aim 3: To examine the preliminary efficacy of the Team-Based SDM Program versus usual care in improving patients' life's essential 8 and medication adherence from baseline to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Team-based shared decision-making | Experimental | Participants in the intervention arm will receive team-based shared decision-making intervention and usual care. |
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| Usual care | No Intervention | Participants in the arm will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Team-based shared decision-making | Combination Product |
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| Measure | Description | Time Frame |
|---|---|---|
| Life's Essential 8 (LE8) | Change in mean LE8 scores from baseline to 6 months post-randomization compared to usual care. LE8 scores ranged from 0 to 100, with higher scores indicating better cardiovascular health. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life as assessed by the Short Form Health Survey - 12 | Patient-centered and patient-reported outcomes - health-related quality of life as measured by the 12-item Short Form Health Survey (SF-12). The SF-12 scores ranged from 0 to 100 and higher scores indicate better health. | 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuling Chen, PhD | Contact | 443-683-5040 | ychen408@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cheryl Himmelfarb, PhD | Johns Hopkins University | Principal Investigator |
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| Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18 |
The Patient Satisfaction Questionnaire (PSQ-18) Short Form. The PSQ-18 scores ranged from 18 to 90, and higher scores reflect better satisfaction with medical care. |
| 3 months and 6 months |
| Shared Decision-Making (SDM) level as assessed by the Collaborate survey | Shared Decision-Making (SDM) level will be measured by the CollaboRATE survey. The CollaboRATE scores ranged from 0-27, with higher scores indicating better SDM level. | 3 months and 6 months |
| Medication adherence as assessed by the Medication Adherence Report Scale -10 | Mean scores of medication adherence assessed by the Medication Adherence Report Scale-10 (MARS-10). Scores range from 0 to 50, or 0 to 10 depending on the exact scoring format used. Higher scores consistently indicate a higher level of medication adherence. | 3 months and 6 months |
| Patients' perceptions of involvement in SDM as assessed by the Patient SDM questionnaire - 9 | Mean scores of patients' perceptions of involvement in SDM assessed by the Patient SDM Questionnaire (SDM-Q-9). The scores ranged from 0 to 45, and higher scores indicate better involvement in SDM. | 3 months and 6 months |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| D007674 | Kidney Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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