Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001669280
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
10/10/2018
Date last updated
10/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A group cardiac rehabilitation program tailored for women
Scientific title
A group cardiac rehabilitation program to improve functional status and self-efficacy in Australian women
Secondary ID [1] 296048 0
ARC DP120101148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 309602 0
Condition category
Condition code
Cardiovascular 308420 308420 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will use a group, mutual aid model to improve knowledge regarding secondary prevention and empowerment of self-management strategies in women. The group will use a mutual aid framework, whereby the leader facilitates group members to help each other. This framework recognises the alliance of individuals to work on mutual issues (Beckie et al 2008).

The intervention will occur in a 4-week, nurse-coordinated program in which a group of 8-12 women will meet weekly for a 2-hour session in an outpatient setting. Each week, a research nurse, trained in the intervention, will facilitate sessions promoting education and awareness, social support, and strategies for behaviour change. A topic schedule will guide the content of each week’s sessions, although formats will remain flexible to allow for emerging issues within groups. Each session is comprised of: a 35-minute educational lecture, 35 minutes of group discussion, 30 minutes of small group activities, and a 20-minute meditation exercise. The facilitator will keep track of intervention adherence by taking attendance at each session. Participants will be reminded to attend the following week's session at the end of weekly sessions. If a participant was not able to attend a session, they received a phone call reminder in advance of the next session. Sessions are based upon empowerment through knowledge and development of an individualized, behavioural change strategy. Key components of the intervention include information about heart disease, changing social roles, the impact of emotions on cardiovascular health, coping with stress, communication, and strategies to promote self-management.

Information about heart disease: The program will commence with providing information about women and heart disease, discussing the signs and symptoms of an acute cardiac event, and the particular risks and problems that they are facing in coping and adjusting to their diagnosis.

Psychosocial aspects: Issues related to coping with changing and multiple roles such as being a caregiver, engaging in home duties, and being a person with a heart condition will be addressed.

Self-efficacy: Belief in one's own capacity to cope with heart disease will be discussed and used as a tool for enhancing self-management of particular target behaviours. Participants will be taught how to self-regulate by selecting specific behaviours they wish to target (e.g. diet, exercise, medication, stress management). Pedometers and diaries will be used to promote self-efficacy for physical activity. Throughout these sessions, the nurse leading the group will provide encouragement to participants in order to maximise participants' self-efficacy, affirming their ability to effectively manage their heart condition.

Anxiety and depression: Cognitive-behavioural therapy (CBT) and mindfulness techniques such as changing self-talk, relaxation, meditation, and time management skills will be included in the program.

Instrumental support: In order to enhance role integration, the program will provide referrals to HomeCare services when applicable (e.g. cooking, cleaning, and washing) to reduce the stress related to women's role of homemaker.

Physical activity: Aspects such as combining a physical activity program in participants' daily schedule will also be addressed according to the guidelines of the National Heart Foundation (Briffa et al 2006). Prompts and reminders, such as pedometers, fridge magnets and diaries will be provided to participants in addition to handouts summarising class discussions (Du et al 2009).

References:
Beckie T, Fletcher G, Beckstead JW. SD, Evans M. Adverse baseline physiological and psychological profiles of women enrolled in a cardiac rehabilitation clinical trial. Journal of Cardiopulmonary Rehabilitation and Prevention. 2008; 28: 52-61.
Briffa T, Maiorana A, Sheerin N, et al. Physical activity for people with cardiovascular disease: Recommendations of the National Heart Foundation of Australia. Med J Aust. 2006; 184: 71-75.
Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: Its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009; 8: 2-8.Schulman LTE. The Skills of Helping Individuals, Families and Groups 1992.
Intervention code [1] 312385 0
Rehabilitation
Intervention code [2] 312386 0
Behaviour
Comparator / control treatment
Usual care means that women will undergo normal procedures and will be able to attend the standard cardiac rehabilitation program offered at the site and other disease management programs. There will be no alteration to the cardiologist or other outpatient follow up appointments or medications unless advised by the relevant health professional, nor any restrictions to using other complementary and alternative therapies.
Following baseline data collection and prior to commencing their first cardiac rehabilitation exercise session, study participants will be randomly assigned to the intervention or to the control group (usual care) by use of a computer-generated program. Conventional cardiac rehabilitation exercise sessions will be undertaken according to national guidelines (Woodruffe et al., 2015). Usual care participants will be reassessed at week 6 and 6 months following the program.

Woodruffe et al. 2015. Australian Cardiovascular Health and Rehabilitation Association (ACRA) Core Components of Cardiovascular Disease Secondary Prevention and Cardiac Rehabilitation 2014. Heart, Lung and Circulation, vol. 24, (5), p. 430-441
Control group
Active

Outcomes
Primary outcome [1] 307387 0
Sub-maximal exercise capacity will be measured using the 6-minute walk test (6MWT), a validated protocol developed by the American Thoracic Society (2002). This test will be conducted by research personnel and documents how far the participant can walk on a measured distance during a 6-minute time period using a standardised protocol.

American Thoracic Society. ATS Statement: Guidelines for the Six-Minute Walk Test. American Journal of Respiratory Critical Care Medicine. 2002; 166: 111-117.
Timepoint [1] 307387 0
Baseline, 6 weeks (primary endpoint), and 6 months
Secondary outcome [1] 351767 0
The General self-efficacy scale (Schwarzer & Jerusalem 1995) will be used to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Criterion-related validity is documented in numerous correlation studies where positive coefficients were found with favourable emotions, dispositional optimism, and work satisfaction. Negative coefficients were found with depression, anxiety, stress, burnout, and health complaints. In studies with cardiac patients, their recovery over a half-year time period could be predicted by pre-surgery self-efficacy.
Timepoint [1] 351767 0
Baseline, 6 weeks, and 6 months
Secondary outcome [2] 351768 0
Depression, anxiety and stress (DASS21): The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. The Depression sub-scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The Anxiety sub-scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The Stress sub-scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. For this study, the short version (DASS 21) will be used. All scales of the DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings and we have used these in the preliminary evaluation of the program.
Timepoint [2] 351768 0
Baseline, 6 weeks, 6 months
Secondary outcome [3] 351769 0
Perceived Health Status: The first item of the SF-36 will be used to ascertain participants' perspective of their overall health. The item asks the participant to rate their health on a 5 point Likert scale.

Ware, J.E., Jr., & Sherbourne, C.D. “The MOS 36-Item Short-Form Health Survey (SF-36): I. Conceptual Framework and Item Selection,”. Medical Care, 30:473-483, 1992.
Timepoint [3] 351769 0
Baseline, 6 weeks, 6 months
Secondary outcome [4] 351770 0
Body Mass Index will be measured using digital scales (weight) and a wall-mounted tape measure (height).
Timepoint [4] 351770 0
Baseline, 6 weeks, 6 months
Secondary outcome [5] 352706 0
Waist–hip ratio will be measured using a tape measure.
Timepoint [5] 352706 0
Baseline, 6 weeks, 6 months
Secondary outcome [6] 352707 0
Blood pressure (mmHg) will be measured using a sphygmomanometer.
Timepoint [6] 352707 0
Baseline, 6 weeks, 6 months
Secondary outcome [7] 352709 0
The number of standard cardiac rehabilitation sessions attended.
Timepoint [7] 352709 0
6 weeks
Secondary outcome [8] 352712 0
The number of standard cardiac rehabilitation sessions attended.
Timepoint [8] 352712 0
6 months
Secondary outcome [9] 352716 0
The number of women's group intervention sessions attended (out of 4)
Timepoint [9] 352716 0
At the conclusion of a 4-week program

Eligibility
Key inclusion criteria
1. Women who are aged 18 years and older and who have had a recent admission to hospital with a cardiac condition, or who have a cardiac diagnosis including acute coronary syndrome or heart failure, or have been referred to cardiac rehabilitation for risk factor modification will be invited to participate.
2. Willing to give informed consent and attend education and participate in a 4-week program and be followed up for 6 months.
3. Clearance by a responsible physician for the patient to exercise
4. Level of English literacy to allow completion of study instruments with minimal assistance
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with unstable angina pectoris
2. Failure to obtain the consent of a responsible physician
3. Cognitive impairment precluding completion of study instruments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine participant eligibility will be unaware of which group the subject is allocated. Allocation involves contacting the holder of the allocation schedule who was "off-site" to obtain intervention or control group designation for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size estimate is based on a projected increase of 20% in the 6-Minute Walk Test (6MWT) in the intervention group from 480 meters to 550 meters following CR (effect size=0.5), based on published literature and experience with an ongoing clinical trial in this population (24). A sample size of 200 participants (100 in the intervention and 100 in the usual care group) at the 6-month follow-up will be required for this study based on a priori, two-tailed power calculations at an alpha of 0.05 which gives an actual power of 0.80.

All analyses will be on the basis of intention to treat. Student’s t-tests will be used for continuous data and chi-square tests will be used for categorical outcomes in univariate analyses. Six Minute Walk Test distances and scores derived from psychometric measures for self-efficacy for exercise, depression, anxiety and stress, social support, and quality of life, are all measured on continuous scales. Non-parametric tests, such as the Kruskal-Wallis test will be applied for comparing means in non-normally distributed variables. Pearson’s correlation for continuous variables will be used to test for associations of selected demographic, social and clinical variables with the subscales and total scale scores for each of the measures. The incidence of readmissions (and 95% confidence intervals) will be calculated for both the intervention and control group. The significance level will be set at p<0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
21/06/2016
Date of last participant enrolment
Anticipated
Actual
13/11/2017
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
200
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11827 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 11828 0
Mount Druitt Hospital - Mount Druitt
Recruitment postcode(s) [1] 23954 0
2148 - Blacktown
Recruitment postcode(s) [2] 23955 0
2770 - Mount Druitt

Funding & Sponsors
Funding source category [1] 300636 0
Government body
Name [1] 300636 0
Australian Research Council Discovery Project
Country [1] 300636 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
PO Box 123
Broadway
New South Wales
2007
Country
Australia
Secondary sponsor category [1] 300155 0
None
Name [1] 300155 0
Address [1] 300155 0
Country [1] 300155 0
Other collaborator category [1] 280380 0
Hospital
Name [1] 280380 0
Blacktown Mount Druitt Hospital
Address [1] 280380 0
18 Blacktown Road
Blacktown NSW 2148
Country [1] 280380 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301425 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301425 0
Ethics committee country [1] 301425 0
Australia
Date submitted for ethics approval [1] 301425 0
12/11/2014
Approval date [1] 301425 0
04/02/2016
Ethics approval number [1] 301425 0
AU RED HREC/15/WMEAD/12
Ethics committee name [2] 301429 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [2] 301429 0
Ethics committee country [2] 301429 0
Australia
Date submitted for ethics approval [2] 301429 0
13/04/2016
Approval date [2] 301429 0
03/05/2016
Ethics approval number [2] 301429 0
ETH160353

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86950 0
A/Prof Michelle DiGiacomo
Address 86950 0
University of Technology Sydney
Faculty of Health
PO Box 123
Broadway
New South Wales
2007
Country 86950 0
Australia
Phone 86950 0
+61 2 9514 4818
Fax 86950 0
Email 86950 0
[email protected]
Contact person for public queries
Name 86951 0
Michelle DiGiacomo
Address 86951 0
University of Technology Sydney
Faculty of Health
PO Box 123
Broadway
New South Wales
2007
Country 86951 0
Australia
Phone 86951 0
+61 2 9514 4818
Fax 86951 0
Email 86951 0
[email protected]
Contact person for scientific queries
Name 86952 0
Michelle DiGiacomo
Address 86952 0
University of Technology Sydney
Faculty of Health
PO Box 123
Broadway
New South Wales
2007
Country 86952 0
Australia
Phone 86952 0
+61 2 9514 4818
Fax 86952 0
Email 86952 0
[email protected]

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