跳至主要内容
临床试验/NCT04294381
NCT04294381招募中不适用

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

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
health self efficacy

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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).

排除标准

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

研究组 & 干预措施

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

干预措施: Decision tool (Behavioral)

结局指标

主要结局

health self efficacy

时间窗: 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

时间窗: 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.

次要结局

  • blood pressure(6 months after intervention initiation)
  • weight(6 months after intervention inititiation)
  • cardiovascular risk(6 months after intervention initiation)
  • experiential avoidance(6 months after intervention initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donna R Zwas

Senior Cardiologist

Hadassah Medical Organization

研究点 (1)

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