Achievement and Adherence to Behavioral Health Goals in the Setting of Patient-Directed Goal Choice

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.

Study Overview

• Status: Recruiting
• Conditions: Sedentary Behavior; Risk Reduction
• Intervention / Treatment: Behavioral: Decision tool

Detailed Description

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.

Patients who participate in the Women's Heart Clinic at Hadassah will be recruited to participate in the study. Patients are to be included in this study if they have undergone cardiovascular event (myocardial infarction, percutaneous coronary intervention, or stroke,) had an active cardiac symptom (e.g. chest pain or arrhythmia) or had 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). Patients are excluded if they arere pregnant, have type 1 diabetes, a psychiatric diagnosis that precluded participation, dementia, or if they were under the care of another multi-disciplinary clinic. The Hadassah Heart Center for Women follows a team-based approach, consisting of a cardiologist, nurse/coordinator, nutritionist, physical therapist/exercise expert and psychologist. At the first visit, patients met with all five professionals. The nurse/coordinator interviews the patient and assists in baseline data collection. The physician obtains the history, conducted physical examinations and determined cardiac care plans. The nutritionist assesses the patient's diet and assists the patient with determining SMART (specific, measurable, achievable, realistic and time-bound) goals using the table tool. The physical therapist/exercise expret performs an assessment of physical activity capacity and behaviors,a 6 minute walk test, and assists the patient in determining SMART goals for increased physical activity. The psychologist assessed patient for active mental health concerns that would interfere with self-care, assisted her in developing a plan to maximize self-care and developed a referral plan for patients who required mental health intervention. Patient cases are reviewed in a multi-disciplinary meeting after the visit and a comprehensive letter including specific recommendations from each member of the team was sent to the patient (In Israel, letters are given to the patient rather than directly to the referring physician.) Follow up appointments are scheduled according to clinical indications.

Baseline data collection included age, medical history, country of birth, education, and monthly income. Cardiac risk factors included the inclusion criteria as described above.

Health behaviors including nutrition behaviors, physical activity behaviors, smoking and alcohol consumption are measured using a culturally-adapted translation of the Healthy Heart Score and Mediterranean Diet Score. The patients fill out the Depression, Anxiety, Stress Score and the Brief Experiential Avoidance Score, health self efficacy and overall quality of life.

Patients will be followed by telephone/video conference at 1 and 2 months, return for follow up visit at month 3, telephone/video conferecnce follow up will be done at months 4 and 5, and the patient will return at month 6 for outcomes evaluation, which will include nutrition and physical activity assessment, and health self efficacy, Health Heart Score, Brief Experiential Avoidance Score, and Health self efficacy. In case of corona restrictions, visits 3 and 6 may be done remotely as well

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donna Zwas, MD; Phone Number: 972-2-677-9452; Email: donnaz1818@gmail.com
• Study Contact Backup: Name: Donna R Zwas, md mph; Phone Number: 972504048274; Email: donnaz1818@gmail.com

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pilot of SMART-goal-setting health behavior decision tool; participants will be asked to use a decision tool to choose and delineate SMART health behavior goals	Behavioral: Decision tool; participants will be asked to use a decision tool to choose and delineate SMART health behavior goals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	kg	6 months after intervention inititiation
cardiovascular risk	hebrew adapted Healthy Heart Score which includes assessment of physical activity, nutrition behaviors, smoking and alcohol consumption	6 months after intervention initiation
experiential avoidance	Brief Experiential Avoidance Questionnaire This is a 15 item scale with answers that range from 1-6 with scores ranging from 15-90 with higher scores reflecting more avoidance	6 months after intervention initiation
blood pressure	systolic and diastolic blood pressure	6 months after intervention initiation

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: March 1, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HMO0094-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Partially, with masking of psychological information, only to researchers with GCP upon request.
• IPD Sharing Time Frame: upon publication
• IPD Sharing Access Criteria: GCP, upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No