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

Sponsor
Queen's University, Belfast (Other)
Overall Status
Completed
CT.gov ID
NCT03276546
Collaborator
Northern Ireland Chest Heart and Stroke (Other)
23
1
8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: shared decision-making tool (SHARE-D)
N/A

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' 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' 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 Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
SHARE-D: a Decision Tool to Help Patients With, or at Risk of, Coronary Heart Disease Make Informed Lifestyle Choices: Feasibility Study
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jan 31, 2017
Actual Study Completion Date :
Jan 31, 2017

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. recruitment rate [4 weeks]

      numbers of responses accepting invitation to participate in study

    Secondary Outcome Measures

    1. completion rate [3 months]

      numbers of enrolled participants who compete all assessments and reviews

    2. diet behaviour [3 months]

      DINE questionnaire

    3. physical activity behaviour [3 months]

      RPAQ questionnaire

    4. objective measure of physical activity [2 periods of 7-day measurement: baseline and after 3 months]

      accelerometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Margaret E Cupples, Professor, Queen's University, Belfast
    ClinicalTrials.gov Identifier:
    NCT03276546
    Other Study ID Numbers:
    • 16/LO/0655
    First Posted:
    Sep 8, 2017
    Last Update Posted:
    May 18, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 18, 2018