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Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (SDM in CKM)

11. august 2026 oppdatert av: Johns Hopkins University

Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

94

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Yuling Chen, PhD
  • Telefonnummer: 443-683-5040
  • E-post: ychen408@jh.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),
  • Are in stage 2 CKM: the presence of metabolic risk factors (hypertension [stages 1 and 2], hypertriglyceridemia [≥135 mg/dL], diabetes, Metabolic Equivalents (MetS)*) and/or Chronic Kidney Disease (CKD) [moderate- to high-risk CKD which are stages 1-3 CKD]), and
  • Receive primary care at Johns Hopkins Community Physicians (JHCP).
  • Access to smart phone or tablet to use app.

Exclusion Criteria:

  • Have diagnosis of CVD,
  • Stage 4-5 CKD, kidney failure, or on dialysis
  • Have a serious medical condition such as cancer;
  • On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;
  • Have cognitive impairment;
  • Are currently involved in other programs on improving LE8; or
  • Unwillingness to provide informed consent
  • Unable to speak, read, or communicate in English.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Team-based shared decision-making
Participants in the intervention arm will receive team-based shared decision-making intervention and usual care.
Kombinasjonsprodukt: Team-based shared decision-making
  1. Patients use the Healthy Heart Patient Decision Aid (PtDA) to prepare for the SDM and track progress: Patients will use the Healthy Heart to self-assess baseline LE8 scores, medication adherence, preferences, and Social Determinants of Health (SDOH) before meeting with pharmacist and primary care providers (PCPs).
  2. Pharmacist-led telehealth SDM visits focus on medication management and lifestyle modifications. The baseline telehealth visit (30-45 minutes) will provide participants with SDM training and the use of Healthy Heart PtDA and assess patients' medications and lifestyle. Follow-up telehealth visits (30 minutes) will be conducted biweekly in the first 2 months and monthly in 3-6 months. Follow-ups will discuss available options, goals, and strategies tailored to the patient's needs and preferences based on the AHA's CKM management algorithm for stage 2 CKM.4 Pharmacist will engage patients in discussions about alternative medication options for metabolic risk factors.
Ingen inngripen: Usual care
Participants in the arm will receive usual care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Life's Essential 8 (LE8)
Tidsramme: 6 months
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health-related quality of life as assessed by the Short Form Health Survey - 12
Tidsramme: 3 months and 6 months
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
Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18
Tidsramme: 3 months and 6 months
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
Tidsramme: 3 months and 6 months
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
Tidsramme: 3 months and 6 months
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
Tidsramme: 3 months and 6 months
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Etterforskere

  • Hovedetterforsker: Cheryl Himmelfarb, PhD, Johns Hopkins University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. september 2026

Primær fullføring (Antatt)

31. mars 2028

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

17. juni 2026

Først innsendt som oppfylte QC-kriteriene

17. juni 2026

Først lagt ut (Faktiske)

23. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00556549
  • 26RIRA1635044 (Annet stipend/finansieringsnummer: American Heart Association)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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