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| [ ...Back to search results ] | [ Print-friendly version ] |
| Home visit vs telephone follow up in Phase II Cardiac Rehabilitation following myocardial infarction: effects on anxiety, depression, attendance at Phase III program and visits to A&E or readmission |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN87281162 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0112186411 |
| Public title | Home visit vs telephone follow up in Phase II Cardiac Rehabilitation following myocardial infarction: effects on anxiety, depression, attendance at Phase III program and visits to A&E or readmission |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Cardiovascular: Cardiac rehabilitation |
| Study hypothesis | Is visiting a patient at home after hospital admission following a heart attack (myocardial infarction) more effective than a telephone call in reducing anxiety and depression, encouraging attendance at Phase III and/or reducing readmission to hospital and visits to Accident and Emergency departments with cardiac symptoms? Phase III refers to exercise and education classes available for 7 weeks, usually starting 4 weeks after myocardial infarction (MI). See appendix A. Secondary Research Objectives: If effective, which types of patients benefit most from home visits? Groups to be examined by age, sex, ethnic origin, attendees v non attendees at Phase III classes, number of risk factors and levels of anxiety and depression during hospital admission. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients admitted to St Helier Hospital with a diagnosis of myocardial infarction (heart attack) during the study period. |
| Participants - exclusion criteria | 1. Patients who are mentally unable to complete a HAD questionnaire eg due to dementia or mental handicap or are considered by the CRNs to be too severely ill to be asked to complete a questionnaire 2. Patients who live too far away to be visited at home 3. Patients with a known history of violence because they may be a threat to the researcher visiting them at home 4. Prisoners, due to their lack of freedom to decide for themselves whether or not to attend exercise and education classes 5. Patients who die, are discharged or are transferred to another hospital without being seen by the CRNs |
| Patient information material | |
| Anticipated start date | 17/07/2006 |
| Anticipated end date | 30/09/2007 |
| Status of trial | Completed |
| Target number of participants | 42 |
| Interventions | Purpose To assess whether patients in the early stage of recovery from an MI after discharge from hospital (Phase II) benefit more from a home visit than they do from a telephone call. Specifically does a home visit: 1. Reduce levels of anxiety and depression more than a telephone call? 2. Encourage attendance at exercise education classes (Phase III)? 3. Decrease the number of visits to A&E and readmissions to hospital with cardiac (heart) symptoms? Null Hypotheses Visiting patients at home after discharge from hospital or telephoning following an MI has the same effect on relieving anxiety and depression. Visiting patients at home after discharge from hospital or telephoning following an MI has the same effect on attendance at Phase III classes. Visiting patients at home after discharge from hospital following an MI or telephoning makes no difference to the number of visits to A&E and readmissions with cardiac symptoms. Design A prospective independent groups design using simple random allocation of patients admitted during the study period to usual care (telephone call) or study intervention (home visit). The same semi-structured interview format will be used during telephone calls and home visits. Telephone calls and home visits will take place within one week of discharge from hospital if possible. A validated questionnaire, the Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression. It will be administered at baseline (Phase I), 4 weeks after the heart attack (at entry to Phase III) and approximately 11 weeks after the heart attack (at the end of Phase III). Methodology The study will involve all patients admitted with a diagnosis of an MI except those who meet the exclusion criteria (see question A23) over a period of approximately 6 weeks until 46 patients have agreed to participate in the study (allowing for nearly 10% of patients in each group to drop out of the study before completion as 21 are required in each group) Eligible patients will be recruited by the cardiac rehabilitation nurse specialists when they are seen on the ward after a diagnosis of a heart attack has been made. The study will be explained and an information sheet will be given to each patient. Patients will be invited to participate in the study and if they give consent will be randomly allocated to usual care or home visit groups using sealed envelopes. They will be asked to complete a HADS questionnaire (as described in question A9) before being discharged from the hospital. A copy of the HADS questionnaire is provided as an appendix to this application. If they are going to be visited at home (the intervention) they will be telephoned first to arrange a convenient date and time. Before they are telephoned the nurse will check that they are not in another hospital (patients are frequently transferred directly from St Holier for angora, usually at St Georges, Tooting) and have not died (normal practice) and inform the researcher. Home visits will be carried out by the researcher, an Occupational Therapist who works in Cardiac Rehabilitation. A semi-structured interview format will be used during the visit and notes will be recorded on the topics discussed. These notes will be filed in the patient's cardiac rehabilitation notes. If they are not going to be visited at home a nurse will telephone them to discuss their progress (usual treatment) using the same semi-structured interview format. All patients will be invited to attend exercise and education classes, usually starting 4 weeks after their heart attack. All patients are normally asked to complete a HADS form just before starting these classes. At the end of the classes (a 7 week course) patients will be asked to fill in a final HADS form. Normally all patients attending the classes are asked to fill one of these in when they finish but patients taking part in this study will also be asked to fill one in if they do not attend or finish the classes. Eleven weeks after their heart attack, or when the patient finishes Phase III classes, the nurse will look up on the hospital computer system whether they have visited Accident and Emergency or been readmitted to hospital with heart problems during this time. This will be recorded in the patient's cardiac rehabilitation notes. Data to be collected 1. Age 2. Sex 3. Ethnic origin 4. HADS scores (on 3 occasions) 5. Attendance at Phase III classes (those who attend at least one class will be considered attendees for the purpose of this study) 6. Number of visits to A&E with cardiac (heart-related) symptoms during Phases II and III 7. Number of days of rehospitalisation with cardiac symptoms during Phases II and III Statistical tests to be used Data analysis will comprise of descriptive and inferential statistics. Due to the nature of the data being collected (questionnaire) this will comprise of frequencies, median and the range. Inferential statistics will be used to detect any significant difference between the two groups (telephone or home visit) in the following variables: To investigate any significant difference in the anxiety levels (assessed by Likert scale) over time (baseline, 4 weeks and 8 weeks) the Friedman statistic will be conducted. To determine any significant differences between the two groups a series of Mann Whitney U tests will be conducted, one for each of the time points. To investigate any significant differences in the attendance (answered attended or did not attend) of Phase III classes between the two groups cross tabulation and the Chi-Square statistic will be used. To investigate the attendance at accident and emergency (number of visits) and re-admissions with cardiac symptoms (number of admissions and days in hospital) between the two groups will be assessed by the Independent t-test. Providing the assumption of normality and homogeneity of variance are passed. If the home visits are found to be more beneficial than telephone calls further analysis will be conducted to discover if particular groups within the intervention group benefited more than others. Patients will be assessed according to age, gender and ethnic origin. This analysis will comprise of cross tabulation and the Chi-Square statistic. All data analyses will be conducted using SPSS for windows (Version 13.0) and alpha will be set at the 0.05 level. Researcher Effects and Bias The researcher is an occupational therapist not a nurse and could therefore have a different approach but a semi-structured interview format, designed jointly, will be used to minimise any differences. Involvement of research participants in design of study None Predictable risks and inconvenience anticipated benefit for participants No risks anticipated. Inconvenience to patients only involves being asked to complete 1 or 2 short questionnaires in addition to normal practice. Partners may take time off work to be present on the visits but may also benefit from being able to ask questions. Hopefully patients will find home visits beneficial. Research indicates that this is the case. If the intervention is successful identifying a means of reducing anxiety, depression and rehospitalisation this will benefit patients and partners. Timetable Weeks 1-6 Recruitment of patients for study. Baseline measurements - record age, sex, ethnic origin and HADS scores for each group. Within 4 days of discharge from hospital the researcher will contact each patient who has been selected for a home visit and arrange to visit as soon as possible. Patients who have been selected to receive a telephone call (usual care) will be contacted by the Cardiac Rehabilitation Nurse Specialists. Visits should be completed within two weeks after the end of the third month unless there are patients whose discharge was delayed in which case some may be later than this. Weeks 5-11 As patients become eligible for Phase III start to record attendance. Patients should start Phase III 4 weeks post-MI but sometimes this is delayed (eg because they have been awaiting additional treatment before being able to start) therefore an additional week has been included to allow for this. Weeks 12-18 Seven weeks after attendance at Phase III was due to commence (non-attendees) or at the end of Phase III (attendees) ask each patient in the study to complete a final HADS form. Score HADS forms and file in patients' notes. At the same time the Cardiac Rehabilitation Nurse Specialists will access patients' records via the computer system and record the number of visits to A&E and any readmissions to hospital with cardiac symptoms in the patients' cardiac rehabilitation notes. After 18th week. analyse findings and start to prepare final report. |
| Primary outcome measure(s) | Levels of anxiety and depression 4 and 11 weeks after MI - expressed as HADS scores. |
| Secondary outcome measure(s) | 1. Attendance at Phase III - expressed as percentage attending at least one session 2. Attendance at A&E readmission to hospital with cardiac symptoms - expressed as number of visits to A&E and or days in hospital |
| Sources of funding | Epsom and St Helier University Hospitals NHS Trust NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall London United Kingdom SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mrs Janet Mc Paul |
| Contact details | Epsom and St. Helier NHS Trust Wrythe Lane Carshalton United Kingdom SM5 1AA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN87281162 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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