Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure

NCT05416879 | Recruiting DMC FDA Device

• 1 other identifier: 308745
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Heart Failure occurs when the heart's ability to pump blood is reduced. Heart failure can lead to symptoms of breathlessness, fatigue and ankle swelling, and result in health complications including damage to other organs (e.g. kidneys), reduced function and quality of life. Although the symptoms of heart failure are similar for men and women, there are sex differences. Lifestyle behaviours such as physical activity are important modifiable risk factor for heart failure. Women continue to be underrepresented in heart failure studies and treatment guidelines are male-derived due to these disparities in recruitment. The purpose of the present study is to evaluate the physical activity levels, sedentary behaviour, sleep and quality of life and understand the barriers and facilitators to these lifestyle behaviours in women newly diagnosed with heart failure.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (9)

• Number of steps per day during a 7-day monitoring period

  7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

  7-day at the time of diagnosis

• Intensity of physical activity (light physical activity, measured in minutes per day) during a 7-day monitoring period

  7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

  7-day at the time of diagnosis

• Intensity of physical activity (moderate physical activity, measured in minutes per day) during a 7-day monitoring period

  7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

  7-day at the time of diagnosis

• Intensity of physical activity (vigorous physical activity, measured in minutes per day) during a 7-day monitoring period

  7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

  7-day at the time of diagnosis

• Time spent sedentary (measured in minutes per day) during a 7-day monitoring period

  7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

  7-day at the time of diagnosis

• Sleep duration (measured in minutes per day) during a 7-day monitoring period

  7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

  7-day at the time of diagnosis

• Change in Baseline Minnesota Living with Heart Failure Questionnaire at 3 months

  A 21-item questionnaire. A 5-point Likert scale used for each question. The questions are summed and the minimum and maximum values are 0-105. A higher score represents a worse health-related quality of life.

  3 months

• Change in Baseline 36-Item Short Form Survey Instrument at 3 months

  A 36-item survey, which includes eight health concepts (physical functioning (10 items), role limitations due to physical health (4 items), role limitations due to emotional problems (3 items), energy/fatigue (4 items), emotional well-being (5 items), social functioning (2 items), pain (2 items) and general health (5 items). Each item is scored 0-100. A higher score represents a better health-related quality of life.

  3 months

• Patient's perceptions of physical activity, sedentary behaviour and quality of life

  A semi-structured interview will explore the barriers and opportunities of past, present and future physical activity, sedentary behaviour and quality of life at the time of diagnosis

  60 minutes

Study Arms (1)

Women newly diagnosed with heart failure

Device: Actigraph GT3X+BT

Interventions

Actigraph GT3X+BT DEVICE

7 day monitoring of physical activity, sedentary behaviour and sleep using the Actigraph GT3X+BT

Women newly diagnosed with heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women newly diagnosed with heart failure

You may qualify if:

• Adult women with a new diagnosis of heart failure after referral to the RVI Heart Failure Diagnostic Clinic;
• Able to walk and perform activities of daily living independently;
• New York Heart Association functional class II-IV;
• Willingness to undertake physical activity monitoring;
• Willingness to participate in a semi-structured interview (this is optional and the participant will be able to participate in the study if they choose not to take part in the interview);
• Ability to read, write and converse in English without the support of an interpreter;
• Able to provide written informed consent.

You may not qualify if:

• Male;
• Already diagnosed with heart failure;
• Presented with severe symptoms requiring urgent assessment and stabilisation (e.g. breathless at rest, hypotension, confusion);
• Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. malignancy, severe respiratory disease, mental health problem);
• Severe physical disability preventing them to function independently;
• Clinically unstable with recent changes in medication;
• Unable to provide informed consent.

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE2, United Kingdom

RECRUITING

Related Publications (16)

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

• Eisenberg E, Di Palo KE, Pina IL. Sex differences in heart failure. Clin Cardiol. 2018 Feb;41(2):211-216. doi: 10.1002/clc.22917. Epub 2018 Feb 27.

  PMID: 29485677 BACKGROUND

• Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.

  PMID: 29174292 BACKGROUND

• Shin JJ, Hamad E, Murthy S, Pina IL. Heart failure in women. Clin Cardiol. 2012 Mar;35(3):172-7. doi: 10.1002/clc.21973.

  PMID: 22389122 BACKGROUND

• Taylor CJ, Ordonez-Mena JM, Jones NR, Roalfe AK, Lay-Flurrie S, Marshall T, Hobbs FDR. National trends in heart failure mortality in men and women, United Kingdom, 2000-2017. Eur J Heart Fail. 2021 Jan;23(1):3-12. doi: 10.1002/ejhf.1996. Epub 2020 Sep 23.

  PMID: 32892471 BACKGROUND

• Cremers, H., et al. Gender differences in Heart Failure; Data on Outcomes and Costs. ESC European Society of Cardiology, 2020

  BACKGROUND

• Charman SJ, Velicki L, Okwose NC, Harwood A, McGregor G, Ristic A, Banerjee P, Seferovic PM, MacGowan GA, Jakovljevic DG. Insights into heart failure hospitalizations, management, and services during and beyond COVID-19. ESC Heart Fail. 2021 Feb;8(1):175-182. doi: 10.1002/ehf2.13061. Epub 2020 Nov 24.

  PMID: 33232587 BACKGROUND

• Cattadori G, Segurini C, Picozzi A, Padeletti L, Anza C. Exercise and heart failure: an update. ESC Heart Fail. 2018 Apr;5(2):222-232. doi: 10.1002/ehf2.12225. Epub 2017 Dec 13.

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• Jakovljevic DG, McDiarmid A, Hallsworth K, Seferovic PM, Ninkovic VM, Parry G, Schueler S, Trenell MI, MacGowan GA. Effect of left ventricular assist device implantation and heart transplantation on habitual physical activity and quality of life. Am J Cardiol. 2014 Jul 1;114(1):88-93. doi: 10.1016/j.amjcard.2014.04.008. Epub 2014 Apr 18.

  PMID: 24925802 BACKGROUND

• Okwose NC, Avery L, O'Brien N, Cassidy S, Charman SJ, Bailey K, Velicki L, Olivotto I, Brennan P, MacGowan GA, Jakovljevic DG. Acceptability, Feasibility and Preliminary Evaluation of a Novel, Personalised, Home-Based Physical Activity Intervention for Chronic Heart Failure (Active-at-Home-HF): a Pilot Study. Sports Med Open. 2019 Nov 27;5(1):45. doi: 10.1186/s40798-019-0216-x.

  PMID: 31776701 BACKGROUND

• Riegel B, Moser DK, Glaser D, Carlson B, Deaton C, Armola R, Sethares K, Shively M, Evangelista L, Albert N. The Minnesota Living With Heart Failure Questionnaire: sensitivity to differences and responsiveness to intervention intensity in a clinical population. Nurs Res. 2002 Jul-Aug;51(4):209-18. doi: 10.1097/00006199-200207000-00001.

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• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

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• Virginia Braun & Victoria Clarke (2006) Using thematic analysis in psychology, Qualitative Research in Psychology, 3:2, 77-101, DOI: 10.1191/1478088706qp063oa

  BACKGROUND

• Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.

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  PMID: 29937585 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sarah Charman, PhD

CONTACT

01912086935; sarah.charman@newcastle.ac.uk

Guy MacGowan, MD

CONTACT

guy.macgowan@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 14, 2022
• Study Start: May 5, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 years

Locations

GB (1)