Sedentary BehaviorNCT04294381
Achievement and Adherence to Behavioral Health Goals in the Setting of Patient-Directed Goal Choice
A study testing Decision tool in people with Sedentary Behavior and Risk Reduction, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Sedentary Behavior, Risk Reduction
- What is being tested?
- Decision tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- pregnancy
- type 1 diabetes
- a psychiatric diagnosis that precludes participation
- dementia
- under the care of another multi-disciplinary clinic.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, 91120
Donna R Zwas, PhD,MPH, 011-972-2-6779451, dannaz@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
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.
Read the 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
- Conditions
- Sedentary Behavior, Risk Reduction
- Being tested
- Decision tool
- Medical subject headings
- Sedentary Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision toolBehavioural
participants will be asked to use a decision tool to choose and delineate SMART health behavior goals
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Decision tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: average of monthly measures at months 1-6.
Secondary outcomes (4)
weight
kg
Measured: 6 months after intervention inititiation
cardiovascular risk
hebrew adapted Healthy Heart Score which includes assessment of physical activity, nutrition behaviors, smoking and alcohol consumption
Measured: 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
Measured: 6 months after intervention initiation
blood pressure
systolic and diastolic blood pressure
Measured: 6 months after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- evaluation of tablet-based decision tool
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna R Zwas, MD MPH, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294381
- Sponsor's protocol ID
- HMO0094-15
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Partially, with masking of psychological information, only to researchers with GCP upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achievement and Adherence to Behavioral Health Goals in the Setting of Patient-Directed Goal Choice
- ClinicalTrials.gov ID
- NCT04294381
- Acronym / sponsor ID
- HMO0094-15
- Conditions
- Sedentary Behavior, Risk Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- evaluation of tablet-based decision tool
| Arm | Type | Receives |
|---|---|---|
| pilot of SMART-goal-setting health behavior decision tool | Experimental | Behavioral: Decision toolparticipants will be asked to use a decision tool to choose and delineate SMART health behavior goals |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- females age 18-90
- who fall into one of the following categories:
Key exclusion criteria (5 listed)
- pregnancy
- type 1 diabetes
- a psychiatric diagnosis that precludes participation
- dementia
- under the care of another multi-disciplinary clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision toolparticipants will be asked to use a decision tool to choose and delineate SMART health behavior goals | Behavioural | pilot of SMART-goal-setting health behavior decision tool |
Primary outcome
health self efficacy
Time frame: 6 months after intervention initiation
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
goal adherence
Time frame: average of monthly measures at months 1-6.
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.
4 secondary outcomes
weight
Time frame: 6 months after intervention inititiation
cardiovascular risk
Time frame: 6 months after intervention initiation
experiential avoidance
Time frame: 6 months after intervention initiation
blood pressure
Time frame: 6 months after intervention initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Yes. Partially, with masking of psychological information, only to researchers with GCP upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna R Zwas, MD MPH principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision tool in people with Sedentary Behavior and Risk Reduction, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Zwas, MD (972-2-677-9452, donnaz1818@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health self efficacy (time frame: 6 months after intervention initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.