SHARE-D: a Decision Tool to Help Patients Make Informed Lifestyle Choices

Health Behavior Clinical Trial

— SHARE-D  

Official title:

SHARE-D: a Decision Tool to Help Patients With, or at Risk of, Coronary Heart Disease Make Informed Lifestyle Choices: Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276546
• Other study ID #: 16/LO/0655
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: January 2024
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

More information is needed about effective ways to help people begin to change their lifestyle behaviours, particularly physical activity and diet. The investigators propose to test a 'tool' that can be used to guide discussions between people and health professionals about their physical activity and diet habits, so that people may be supported better in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines and make long-term changes. The investigators will explore the feasibility of using this tool in general practice, reviewing behaviours after 1 and 3 months. Patients' and healthcare professionals' views of its use and how it influenced decisions will inform development of the tool's design and a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles.

Description:

Healthier lifestyles, relating to physical activity and diet, reduce the risk of heart disease and stroke. However, making and sustaining lifestyle changes is difficult. More information is needed about effective ways to help people begin to change their lifestyle behaviours. The investigators propose to test the feasibility of using a 'tool' (the SHARED-D questionnaire) in guiding discussions between people and health professionals about physical activity and diet, and support people in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines. The 'tool' (SHARE-D) consists of questions to help people think about their personal circumstances and their motivation, opportunities, capabilities and priorities, and includes information about heart disease and stroke.

The investigators will explore the use of this tool in general practice, assessing patients' physical activity and diet behaviour after 1 and 3 months. Patients' and healthcare professionals' views of its use and how it influenced decisions will help to improve the tool's design. Participants' opinions regarding its format and method of delivery will inform future plans for its use and the design of a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles, hoping to lead to improved quality of life for people with heart disease and stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or over

• With or at high risk of coronary heart disease

• Overweight or physically inactive

Exclusion Criteria:

• Unable to complete questionnaires

• Unable to make independent changes to physical activity or diet habits

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• shared decision-making tool (SHARE-D)
questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	Northern Ireland Chest Heart and Stroke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	numbers of patients attending a baseline assessment, compared to numbers invited to participate	4 months overall recruitment (responses to invitations recorded within 4 weeks of invitation being sent)
Secondary	Completion Rate	numbers of enrolled participants who complete all assessments and reviews	3 months
Secondary	Diet Behaviour - Fibre Intake	Dietary Instrument for Nutritional Education (DINE) questionnaire - measure of diet fibre content; maximum score = 61; minimum = 3; higher score indicates better outcome	3 months
Secondary	Physical Activity Behaviour	RPAQ questionnaire -self-reported frequency of episodes of different activities representing levels of sedentary behaviour and of light, moderate and vigorous physical activity in 4 weeks prior to completion of the questionnaire; focus on measure of sedentary behaviour indicated by time (hours) spent watching TV/weekday	3 months
Secondary	Objective Measure of Physical Activity	accelerometer measurement of duration of light, moderate and vigorous physical activity per day over a 7-day period	2 periods of 7-day measurement: baseline and after 3 months