Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
82 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-07-24
Study Completion Date
2020-01-30
Brief Summary
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Cardiac rehabilitation is a programme of exercise and health advice for people recovering from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic lung disease. For both groups of patients, taking part in rehabilitation can lead to improvements in health and well-being. However, only 30% of patients complete their agreed rehabilitation programme. This costs the NHS millions of pounds every year. This project aims to investigate whether a motivational-based intervention, underpinned by self-determination theory and motivational interviewing, will enable staff to encourage more patients to take part in physical activity (PA). Staff will be trained with the new communication skills and will then deliver the rehabilitation programme. The session content will not change, just the way in which staff speak to patients.
This will be a two-phase study. Phase A will take a qualitative approach collect patient and staff feedback about the current rehabilitation programme, before using this information to develop and pilot the intervention. Phase B will then assess the feasibility of the intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part in the phase B will be required to complete an interview and questionnaire at three time points. Patients' personal opinions of the programmes will be extremely important in discovering what can be done to improve rehabilitation for future participants.
The main objectives will be to look at whether the intervention increases the number of patients taking part in physical activity. The investigators plan to establish how much physical activity patients take part in whilst they are in rehabilitation, as well as once they have left the programme. This is why participants will be interviewed three and six months after they have finished their rehabilitation programme.
This will be a two-phase study. Phase A will take a qualitative approach collect patient and staff feedback about the current rehabilitation programme, before using this information to develop and pilot the intervention. Phase B will then assess the feasibility of the intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part in the phase B will be required to complete an interview and questionnaire at three time points. Patients' personal opinions of the programmes will be extremely important in discovering what can be done to improve rehabilitation for future participants.
The main objectives will be to look at whether the intervention increases the number of patients taking part in physical activity. The investigators plan to establish how much physical activity patients take part in whilst they are in rehabilitation, as well as once they have left the programme. This is why participants will be interviewed three and six months after they have finished their rehabilitation programme.
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Detailed Description
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Background and Rationale
Description of research questions and justification for undertaking the trial Cardiac Rehabilitation (CR) is an effective treatment for CHD and CVD patients, boasting a range of physiological and psychological benefits as well as lowering mortality and risk of secondary cardiac incidents. Despite the aforementioned benefits of CR attendance, uptake and adherence to CR remain inadequate, with cross-cultural surveys demonstrating that only 10-30% of eligible CR patients engage in such programmes. These poor levels of CR participation have been previously attributed to low referral rates amongst healthcare providers, however even within the 30% of eligible patients who become CR participants, the attrition rate is currently 50% and only 20% of attendees report long-term behavioural change. The lack of subsequent engagement with the desired adaptive behaviours is at a great cost to the National Health Service (NHS), with the cost of delivering a "good quality CR service" at £477 per patient and the average cardiac readmission costing £3637. Although physical activity (PA) has been demonstrated to reduce the risk of secondary cardiac incidents, 80% of CR patients fail to maintain regular habitual PA within the first year following a course of CR..
Similarly, Pulmonary Rehabilitation (PR) has been demonstrated to be an effective non-pharmacological intervention for COPD patients, and aims to return the patient to independent functioning, reduce disability and improve quality of life. The clinical conditions for which PR is routinely offered result in progressive loss of function over time. Therefore, any initial beneficial effects of a PR programme are likely to diminish over the subsequent eighteen months. Within this time period however, patients who complete PR have significantly greater quality of life, PA capacity, and fewer days in hospital relative to participants who do not participate in PR . Despite these benefits, uptake and adherence to PR is extremely problematic, with studies demonstrating that less than 50% of patients referred to PR will complete the course. Additionally, adherence rates reported in randomised controlled trials tend to be higher, so even this bleak estimate of adherence may be inflated.
Background Information
A commonality between CR and PR is the patients' participation in physical activity. Regular participation in physical activity (PA) reduces all-cause mortality by 30%, and can help to manage over 20 chronic conditions, including CHD, stroke, type 2 diabetes, cancer, obesity, mental health problems and musculoskeletal conditions. COPD patients' engagement in low-to-moderate intensity daily PA has been shown to enhance their cardiorespiratory health and ability for exertion, and reduce dyspnoea symptoms . Additionally, PA reduces cardiac mortality by 31%, and has been demonstrated to lower blood pressure, and increase 'good' cholesterol in cardiac patients. These effects occur through engagement in relatively low levels of activity: 30 minutes, five times per week.
Despite these far-reaching benefits, patients are less likely than non-symptomatic individuals to engage with PA. In 2015, a report by the Academy of Medical Royal Colleges portrayed PA as a 'miracle cure', which despite having a better disease risk reduction than many drugs, is often overlooked by healthcare providers and their patients. Worryingly, with the number of older people with multiple medical problems increasing rapidly, less than a third of UK adults over the age of 65 meet the minimum levels of PA.
Theoretical Underpinning
Motivation is a key component of behaviour change. With the focus on the motivational aspects of behaviour change in mind, Self-Determination Theory (SDT) has become an increasingly commonly used theory to design health behaviour change interventions . According to SDT individuals adopt or change behaviour on the basis of internal satisfaction and fulfilment, termed as intrinsic motivation. Alternatively, individuals are less likely to adopt or change behaviour when a reward or inducement provided by an external person is used to compel a person to act, known as extrinsic motivation. Environments that support intrinsic motivation optimise behavioural effort, persistence and performance. In contrast, environments that coerce through rewards serve to diminish behavioural effort, persistence and performance .
Previous SDT research has demonstrated that intrinsic motivation towards treatment is positively associated with adherence to medical regimes among people with chronic illnesses, attendance/involvement in an addiction treatment program, and long-term maintenance of weight loss among morbidly obese patients. Within physical activity research, intrinsic motivation has been found to be strongly associated with physical activity engagement. Similarly, increases in intrinsic motivation from pre- to post- exercise referral scheme significantly predicted greater adherence to the scheme as well as greater sports-related physical activity. The dense body of SDT research in health, including physical activity, suggests that interventions underpinned by SDT, should develop and support intrinsic motivation in order to optimally motivate engagement with PA.
Motivational interviewing (MI) is a method of strengthening personal motivation for change, and has been shown to be a promising approach for promoting health behaviour change in a number of contexts including physical activity promotion. MI comprises several techniques used by practitioners to facilitate behaviour change in patients. Some techniques focus on the content of the intervention, whereas others focus on techniques reflect the practitioner's interpersonal style of delivery. One of the primary roles the MI approach is to evoke the patient's arguments for change and to reduce their own arguments for not changing.
Research Critique
Motivational theories that inform behaviour change (for example, SDT) do not typically feed through to into instructor training programmes, particularly in clinical rehabilitation settings. Therefore, a significant limitation of motivational theory to date is its ability to be translated into clinical practice. Accordingly, it is important that attempts are made to ensure motivational theory is translated effectively in clinical practice in order to increase patients' motivation for physical activity uptake and adherence in cardiac and pulmonary rehabilitation. The current research, therefore, will combine a well-established motivational theory (i.e., Self-Determination Theory) with established motivational practice (i.e., Motivational Interviewing) in an attempt to integrate theory and practice, offsetting Ntoumanis et al's. claims that contemporary motivation research does not typically feed through to instructor programmes.
Previous researches aiming to increase physical activity motivation in rehabilitation have predominantly focused on interventions at an individual-level. Whilst it is important not to completely disregard this approach, the NHS rehabilitation setting is typically a place where clinicians have to facilitate sessions on a group-level. Furthermore, the NHS may not have the resources to provide the sufficient level of treatment fidelity that one-to-one approaches require in order to be successful. Therefore, the current research will equip clinicians with skills to be effective for increasing group-level physical activity motivation, as well as on an individual level.
Motivational-based intervention research for changing increasing physical activity behaviour in clinical rehabilitation settings has predominantly focused on intervention effectiveness for changing behavioural outcomes. However, the intervention development, delivery and content are not often reported, therefore, limiting the applied utility and replication of the intervention itself. As such, the current research will pilot and feasibly investigate the development of a motivational-based intervention. Doing so will provide a more nuanced understanding for motivating cardiac and pulmonary patients' uptake and adherence to physical rehabilitation activity. Such information would also be crucial for informing a future RCT trial.
Description of research questions and justification for undertaking the trial Cardiac Rehabilitation (CR) is an effective treatment for CHD and CVD patients, boasting a range of physiological and psychological benefits as well as lowering mortality and risk of secondary cardiac incidents. Despite the aforementioned benefits of CR attendance, uptake and adherence to CR remain inadequate, with cross-cultural surveys demonstrating that only 10-30% of eligible CR patients engage in such programmes. These poor levels of CR participation have been previously attributed to low referral rates amongst healthcare providers, however even within the 30% of eligible patients who become CR participants, the attrition rate is currently 50% and only 20% of attendees report long-term behavioural change. The lack of subsequent engagement with the desired adaptive behaviours is at a great cost to the National Health Service (NHS), with the cost of delivering a "good quality CR service" at £477 per patient and the average cardiac readmission costing £3637. Although physical activity (PA) has been demonstrated to reduce the risk of secondary cardiac incidents, 80% of CR patients fail to maintain regular habitual PA within the first year following a course of CR..
Similarly, Pulmonary Rehabilitation (PR) has been demonstrated to be an effective non-pharmacological intervention for COPD patients, and aims to return the patient to independent functioning, reduce disability and improve quality of life. The clinical conditions for which PR is routinely offered result in progressive loss of function over time. Therefore, any initial beneficial effects of a PR programme are likely to diminish over the subsequent eighteen months. Within this time period however, patients who complete PR have significantly greater quality of life, PA capacity, and fewer days in hospital relative to participants who do not participate in PR . Despite these benefits, uptake and adherence to PR is extremely problematic, with studies demonstrating that less than 50% of patients referred to PR will complete the course. Additionally, adherence rates reported in randomised controlled trials tend to be higher, so even this bleak estimate of adherence may be inflated.
Background Information
A commonality between CR and PR is the patients' participation in physical activity. Regular participation in physical activity (PA) reduces all-cause mortality by 30%, and can help to manage over 20 chronic conditions, including CHD, stroke, type 2 diabetes, cancer, obesity, mental health problems and musculoskeletal conditions. COPD patients' engagement in low-to-moderate intensity daily PA has been shown to enhance their cardiorespiratory health and ability for exertion, and reduce dyspnoea symptoms . Additionally, PA reduces cardiac mortality by 31%, and has been demonstrated to lower blood pressure, and increase 'good' cholesterol in cardiac patients. These effects occur through engagement in relatively low levels of activity: 30 minutes, five times per week.
Despite these far-reaching benefits, patients are less likely than non-symptomatic individuals to engage with PA. In 2015, a report by the Academy of Medical Royal Colleges portrayed PA as a 'miracle cure', which despite having a better disease risk reduction than many drugs, is often overlooked by healthcare providers and their patients. Worryingly, with the number of older people with multiple medical problems increasing rapidly, less than a third of UK adults over the age of 65 meet the minimum levels of PA.
Theoretical Underpinning
Motivation is a key component of behaviour change. With the focus on the motivational aspects of behaviour change in mind, Self-Determination Theory (SDT) has become an increasingly commonly used theory to design health behaviour change interventions . According to SDT individuals adopt or change behaviour on the basis of internal satisfaction and fulfilment, termed as intrinsic motivation. Alternatively, individuals are less likely to adopt or change behaviour when a reward or inducement provided by an external person is used to compel a person to act, known as extrinsic motivation. Environments that support intrinsic motivation optimise behavioural effort, persistence and performance. In contrast, environments that coerce through rewards serve to diminish behavioural effort, persistence and performance .
Previous SDT research has demonstrated that intrinsic motivation towards treatment is positively associated with adherence to medical regimes among people with chronic illnesses, attendance/involvement in an addiction treatment program, and long-term maintenance of weight loss among morbidly obese patients. Within physical activity research, intrinsic motivation has been found to be strongly associated with physical activity engagement. Similarly, increases in intrinsic motivation from pre- to post- exercise referral scheme significantly predicted greater adherence to the scheme as well as greater sports-related physical activity. The dense body of SDT research in health, including physical activity, suggests that interventions underpinned by SDT, should develop and support intrinsic motivation in order to optimally motivate engagement with PA.
Motivational interviewing (MI) is a method of strengthening personal motivation for change, and has been shown to be a promising approach for promoting health behaviour change in a number of contexts including physical activity promotion. MI comprises several techniques used by practitioners to facilitate behaviour change in patients. Some techniques focus on the content of the intervention, whereas others focus on techniques reflect the practitioner's interpersonal style of delivery. One of the primary roles the MI approach is to evoke the patient's arguments for change and to reduce their own arguments for not changing.
Research Critique
Motivational theories that inform behaviour change (for example, SDT) do not typically feed through to into instructor training programmes, particularly in clinical rehabilitation settings. Therefore, a significant limitation of motivational theory to date is its ability to be translated into clinical practice. Accordingly, it is important that attempts are made to ensure motivational theory is translated effectively in clinical practice in order to increase patients' motivation for physical activity uptake and adherence in cardiac and pulmonary rehabilitation. The current research, therefore, will combine a well-established motivational theory (i.e., Self-Determination Theory) with established motivational practice (i.e., Motivational Interviewing) in an attempt to integrate theory and practice, offsetting Ntoumanis et al's. claims that contemporary motivation research does not typically feed through to instructor programmes.
Previous researches aiming to increase physical activity motivation in rehabilitation have predominantly focused on interventions at an individual-level. Whilst it is important not to completely disregard this approach, the NHS rehabilitation setting is typically a place where clinicians have to facilitate sessions on a group-level. Furthermore, the NHS may not have the resources to provide the sufficient level of treatment fidelity that one-to-one approaches require in order to be successful. Therefore, the current research will equip clinicians with skills to be effective for increasing group-level physical activity motivation, as well as on an individual level.
Motivational-based intervention research for changing increasing physical activity behaviour in clinical rehabilitation settings has predominantly focused on intervention effectiveness for changing behavioural outcomes. However, the intervention development, delivery and content are not often reported, therefore, limiting the applied utility and replication of the intervention itself. As such, the current research will pilot and feasibly investigate the development of a motivational-based intervention. Doing so will provide a more nuanced understanding for motivating cardiac and pulmonary patients' uptake and adherence to physical rehabilitation activity. Such information would also be crucial for informing a future RCT trial.
Conditions
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Cardiovascular Diseases
Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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Phase A, Study One
Semi-structured interviews to investigate staff and patients' experiences of participating and facilitating cardiac and pulmonary rehabilitation.
No interventions assigned to this group
Phase A, Study Two
Focus group with rehabilitation stakeholders to discuss perceived feasibility and acceptability of the intervention design.
No interventions assigned to this group
Phase A, Study Three
Pilot of the intervention, using a group of exercise physiologists external to the community rehabilitation services.
IPAIR
Intervention Type
BEHAVIORAL
Motivational interview training
Phase B
Community rehabilitation service staff will participate in the intervention. Patients will then participate in the rehabilitaiton programme. Physical activity levels of patients will be recorded throughout the rehabilitation programme and for six months post-discharge. Qualitative and quantitative follow-up sessions will patients will take place at discharge (8 weeks after start of rehabilitation), and three and six months post-discharge.
IPAIR
Intervention Type
BEHAVIORAL
Motivational interview training
Interventions
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IPAIR
Motivational interview training
Intervention Type
BEHAVIORAL
Other Intervention Names
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Motivational interview training
Eligibility Criteria
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Inclusion Criteria
1. Inclusion criteria - Patients will be included when they enrol into cardiac and pulmonary rehabilitation programme due to heart disease or chronic obstructive pulmonary disease. 2.
Exclusion Criteria
Exclusion criteria - They will be excluded if they have previously completed a cardiac/pulmonary rehabilitation programme.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Edge Hill University
OTHER
Sponsor Role
collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Adrian W Midgley, PhD
Role: PRINCIPAL_INVESTIGATOR
Liverpool Heart and Chest Hospital NHS Foundation Trust/ Edge Hill University
Bashir Matata, PhD
Role: PRINCIPAL_INVESTIGATOR
Liverpool Heart and Chest Hospital NHS Foundation Trust
Locations
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Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Site Status
Countries
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United Kingdom
References
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Arnold E, Bruton A, Ellis-Hill C. Adherence to pulmonary rehabilitation: A qualitative study. Respir Med. 2006 Oct;100(10):1716-23. doi: 10.1016/j.rmed.2006.02.007. Epub 2006 Mar 22.
Reference Type
BACKGROUND
Bjarnason-Wehrens B, Bott D, Benesch L, Bischoff KO, Buran-Kilian B, Gysan D, Hollenstein U, Mayer-Berger W, Wilkniss R, Sauer G. Long-term results of a three-week intensive cardiac out-patient rehabilitation program in motivated patients with low social status. Clin Res Cardiol. 2007 Feb;96(2):77-85. doi: 10.1007/s00392-007-0461-0. Epub 2006 Dec 14.
Reference Type
BACKGROUND
British Heart Foundation. (2015). The National Audit of Cardiac Rehabilitation Annual Statistical Report 2015. London. Retrieved from http://www.cardiacrehabilitation.org.uk/docs/2007.pdf
Reference Type
BACKGROUND
British Thoracic Society (BTS). (2013). BTS Guideline on Pulmonary Rehabilitation in Adults. An International Journal of Respiratory Medicine, 68(2), ii1-31. https://doi.org/10.1136/thoraxjnl-2013-203808
Reference Type
BACKGROUND
Chan DK, Lonsdale C, Ho PY, Yung PS, Chan KM. Patient motivation and adherence to postsurgery rehabilitation exercise recommendations: the influence of physiotherapists' autonomy-supportive behaviors. Arch Phys Med Rehabil. 2009 Dec;90(12):1977-82. doi: 10.1016/j.apmr.2009.05.024.
Reference Type
BACKGROUND
Clark RA, Conway A, Poulsen V, Keech W, Tirimacco R, Tideman P. Alternative models of cardiac rehabilitation: a systematic review. Eur J Prev Cardiol. 2015 Jan;22(1):35-74. doi: 10.1177/2047487313501093. Epub 2013 Aug 13.
Reference Type
BACKGROUND
De Amici D, Klersy C, Ramajoli F, Brustia L, Politi P. Impact of the Hawthorne effect in a longitudinal clinical study: the case of anesthesia. Control Clin Trials. 2000 Apr;21(2):103-14. doi: 10.1016/s0197-2456(99)00054-9.
Reference Type
BACKGROUND
Deci, E. L., & Ryan, R. M. (2008). Facilitating optimal motivation and psychological well-being across life's domains. Canadian Psychology/Psychologie Canadienne, 49(1), 14-23. https://doi.org/10.1037/0708-5591.49.1.14
Reference Type
BACKGROUND
Hardcastle SJ, Fortier M, Blake N, Hagger MS. Identifying content-based and relational techniques to change behaviour in motivational interviewing. Health Psychol Rev. 2017 Mar;11(1):1-16. doi: 10.1080/17437199.2016.1190659. Epub 2016 Jun 2.
Reference Type
BACKGROUND
Hospes G, Bossenbroek L, Ten Hacken NH, van Hengel P, de Greef MH. Enhancement of daily physical activity increases physical fitness of outclinic COPD patients: results of an exercise counseling program. Patient Educ Couns. 2009 May;75(2):274-8. doi: 10.1016/j.pec.2008.10.005. Epub 2008 Nov 25.
Reference Type
BACKGROUND
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
Reference Type
BACKGROUND
Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.
Reference Type
BACKGROUND
National Institute for Health and Clinical Excellence (NICE). (2013). Cardiac rehabilitation services: commissioning guide. London.
Reference Type
BACKGROUND
Ntoumanis N, Thogersen-Ntoumani C, Quested E, Hancox J. The effects of training group exercise class instructors to adopt a motivationally adaptive communication style. Scand J Med Sci Sports. 2017 Sep;27(9):1026-1034. doi: 10.1111/sms.12713. Epub 2016 Jun 10.
Reference Type
BACKGROUND
Prestwich, A., Webb, T. L., & Conner, M. (2015). Using theory to develop and test interventions to promote changes in health behaviour: Evidence, issues, and recommendations. Current Opinion in Psychology, 5(February), 1-5. https://doi.org/10.1016/j.copsyc.2015.02.011
Reference Type
BACKGROUND
Rahman RJ, Thogersen-Ntoumani C, Thatcher J, Doust J. Changes in need satisfaction and motivation orientation as predictors of psychological and behavioural outcomes in exercise referral. Psychol Health. 2011 Nov;26(11):1521-39. doi: 10.1080/08870446.2010.538849. Epub 2011 Jun 16.
Reference Type
BACKGROUND
Russell KL, Bray SR. Promoting self-determined motivation for exercise in cardiac rehabilitation: the role of autonomy support. Rehabil Psychol. 2010 Feb;55(1):74-80. doi: 10.1037/a0018416.
Reference Type
BACKGROUND
Silva MN, Vieira PN, Coutinho SR, Minderico CS, Matos MG, Sardinha LB, Teixeira PJ. Using self-determination theory to promote physical activity and weight control: a randomized controlled trial in women. J Behav Med. 2010 Apr;33(2):110-22. doi: 10.1007/s10865-009-9239-y. Epub 2009 Dec 11.
Reference Type
BACKGROUND
Singh SJ, Smith DL, Hyland ME, Morgan MD. A short outpatient pulmonary rehabilitation programme: immediate and longer-term effects on exercise performance and quality of life. Respir Med. 1998 Sep;92(9):1146-54. doi: 10.1016/s0954-6111(98)90410-3.
Reference Type
BACKGROUND
Speake H, Copeland RJ, Till SH, Breckon JD, Haake S, Hart O. Embedding Physical Activity in the Heart of the NHS: The Need for a Whole-System Approach. Sports Med. 2016 Jul;46(7):939-46. doi: 10.1007/s40279-016-0488-y.
Reference Type
BACKGROUND
Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012 Jun 22;9:78. doi: 10.1186/1479-5868-9-78.
Reference Type
BACKGROUND
The Academy of Medical Royal Colleges. (2015). Exercise: The miracle cure and the role of the doctor in promoting it. Report from the Academy of Medical Royal Colleges. London. Retrieved from http://www.aomrc.org.uk
Reference Type
BACKGROUND
Yohannes AM, Doherty P, Bundy C, Yalfani A. The long-term benefits of cardiac rehabilitation on depression, anxiety, physical activity and quality of life. J Clin Nurs. 2010 Oct;19(19-20):2806-13. doi: 10.1111/j.1365-2702.2010.03313.x. Epub 2010 Aug 24.
Reference Type
BACKGROUND
Other Identifiers
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LiverpoolHeartNHS
Identifier Type: -
Identifier Source: org_study_id
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