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

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: shared decision-making tool (SHARE-D)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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: SHARE-D decision tool use; The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour	Behavioral: shared decision-making tool (SHARE-D); questionnaire; Other Names: questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate	numbers of enrolled participants who complete all assessments and reviews	3 months
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
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
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

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: Northern Ireland Chest Heart and Stroke

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 16/LO/0655

Drug and device information, study documents

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