NCT04294381

Brief Summary

Health care decisions should include patients' health outcome goals and care preferences so as to enable a unified set of individualized patient outcome goals, rather than disparate disease-specific goals that do not reflect patient choice and commitment. This study utilizes a skilled professional interview and a simple tablet-based tool to enable patient choice of health behavior goals. The tool guides the patient to choose a specific, measurable, attainable, realistic and time-based (SMART) goal. The hypothesis of this study is that the implementation this patient choice tool will increase the likelihood of patient adherence to the goal and increase patient self efficacy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Sep 2020Jun 2026

First Submitted

Initial submission to the registry

October 27, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5.3 years

First QC Date

October 27, 2019

Last Update Submit

April 23, 2023

Conditions

Sedentary BehaviorRisk Reduction

Outcome Measures

Primary Outcomes (2)

  • health self efficacy

    self report measure adapted from Moore and McBride 2009 that consists of 2 questions, on a scale of 0-10, how much do i want change and how much am I capable of change, with 10 reflecting higher self efficacy

    6 months after intervention initiation

  • goal adherence

    Goal Attainment Scale for rehabilitation. This is scaled from -3 to +2, with +2 representing goal attainment far beyond anticipated, 0 representing goal achievement and -2 representing worsening. Higher is better.

    average of monthly measures at months 1-6.

Secondary Outcomes (4)

  • weight

    6 months after intervention inititiation

  • cardiovascular risk

    6 months after intervention initiation

  • experiential avoidance

    6 months after intervention initiation

  • blood pressure

    6 months after intervention initiation

Study Arms (1)

pilot of SMART-goal-setting health behavior decision tool

EXPERIMENTAL

participants will be asked to use a decision tool to choose and delineate SMART health behavior goals

Behavioral: Decision tool

Interventions

Decision toolBEHAVIORAL

participants will be asked to use a decision tool to choose and delineate SMART health behavior goals

pilot of SMART-goal-setting health behavior decision tool

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself identified as women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • females age 18-90
  • who fall into one of the following categories:
  • undergone cardiovascular event (myocardial infarction, percutaneous coronary intervention, or stroke,) or
  • who have an active cardiac symptom (e.g. chest pain or arrhythmia) or
  • have three or more active risk factors (i.e. diabetes, hypertension, hyperlipidemia, peripheral artery disease, current smoker, family history of premature coronary disease, gestational diabetes, pregnancy-induced hypertension/pre-eclampsia, or obesity).

You may not qualify if:

  • pregnancy
  • type 1 diabetes
  • a psychiatric diagnosis that precludes participation
  • dementia
  • under the care of another multi-disciplinary clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Donna R Zwas, MD MPH

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Zwas, MD

CONTACT

972-2-677-9452donnaz1818@gmail.com

Donna R Zwas, md mph

CONTACT

972504048274donnaz1818@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: evaluation of tablet-based decision tool
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Cardiologist

Study Record Dates

First Submitted

October 27, 2019

First Posted

March 4, 2020

Study Start

September 1, 2020

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Partially, with masking of psychological information, only to researchers with GCP upon request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
upon publication
Access Criteria
GCP, upon request

Locations

IL(1)