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IRCT2014101919593N1 IRCT 2014-10-25 No sponsor Family focused Approach to iMprove Heart Failure care In Lebanon QualitY (FAMILY) Intervention FAMILY Family focused Approach to iMprove Heart Failure care In Lebanon QualitY (FAMILY) Intervention 2013-10-31 anticipated 260 Complete https://irct.ir/trial/17503 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Heart Failure. Intervention 1: Both groups will be approached at baseline. The study will be introduced and the participants along with their family caregivers will be consented to participate. Baseline data collection will be done to included: socio-demographic data, social and medical history, physical assessment, laboratory values, discharge medication and frailty scale. Also the translated version of the quality of life questionnaire and that of the self-care of heart failure index will be collected. Patients will then randomized into the control group and the intervention group based on a unique allocated code to each participant. The second encounter will define the difference between the control and the intervention group. During this encounter both groups will be provided with a scale, a calibrated bottle, a medication box and a diary. This encounter will differ between the two groups in the following manner: a- The control group, when approached, will be provided with a packed bag of the aforementioned items. No verbal explanation will be provided to the group rather they will be provided with a paper containing the instructions of how to use those items. Intervention 2: Both groups will be approached at baseline. The study will be introduced and the participants along with their family caregivers will be consented to participate. Baseline data collection will be done to included: socio-demographic data, social and medical history, physical assessment, laboratory values, discharge medication and frailty scale. Also the translated version of the quality of life questionnaire and that of the self-care of heart failure index will be collected. Patients will then randomized into the control group and the intervention group based on a unique allocated code to each participant. The second encounter will define the difference between the control and the intervention group. During this encounter both groups will be provided with a scale, a calibrated bottle, a medication box and a diary. This encounter will differ between the two groups in the following manner: b- The intervention group: a family conference will take place with the patient and their family carer extending for 60-90 min depending on necessity. This conference will be tailored to their condition, unique symptoms (if present) and subjective demands. The educational session will be structured to include information about heart failure causes, symptoms and management. The latter will comprise a big portion of the educational session focusing on self-management and roles of the family caregiver. Education will include points about salt and fluid restriction, physical activity, symptom recognition, smoking cessation, and adherence to prescribed medication in addition to the aforementioned culture specific practices. Items in the bag will be explained separately emphasising the need to have the medication box filled, with the daily pills according to the prescribed dosages, by the family carer, monitor fluid intake as recommended by their cardiologist with the help of the calibrated bottle used to store the daily fluid allowance, weigh daily after waking up in the morning with light clothes, and documenting the weight in the provided diary. In consultation with their treating cardiologist, a flexible diuretic plan will be implemented. Participants will be instructed to take an extra pill of their diuretic if their weight increases by 1kg over 24 hours or 2kg over 5 days. They will also be advised to contact their cardiologist if weight continues to increase despite the proposed plan. Both groups will be provided with contact details of their cardiologist and the specialist nurse to refer to in case of an emergency.
public Hiba Deek
Broadway
Sydney Australia 2007 00610402315084 hiba.a.deek@student.uts.edu.au University of Technology Sydney scientific Hiba Deek
Broadway
Sydney Australia 2007 00610402315084 hiba.a.deek@student.uts.edu.au University of Technology Sydney Lebanon Lebanon Selection Criteria Inclusion criteria: All those admitted to the site hospital for acute decompensated HF regardless of the aetiology, aged >18 years and willing to participate will be included in this study. The family member nominated by the patient should be willing to care for the patient and participate in the study. Patients with illiteracy will be included if their family caregiver is literate and can reach a proper decision in favour of their patient. Patients will be asked to finger print the consent form after a thorough explanation is provided about the intervention and adequate support is provided by the caregiver. Exclusion criteria Patients having limited life expectancy of less than 30 days, severe cognitive impairment limiting their judgement and activity, pending cardiac bypass or valve replacement surgery with limited functionality, living alone or in nursing home, and aged less than 18 years will be excluded. Also conditions that hinder the progress of the intervention such as impaired cognition or blindness of the caregiver exclude the possible participants. 18 years 139 years Both I50.0 Congestive heart failure N/A Treatment - Other Both groups will be approached at baseline. The study will be introduced and the participants along with their family caregivers will be consented to participate. Baseline data collection will be done to included: socio-demographic data, social and medical history, physical assessment, laboratory values, discharge medication and frailty scale. Also the translated version of the quality of life questionnaire and that of the self-care of heart failure index will be collected. Patients will then randomized into the control group and the intervention group based on a unique allocated code to each participant. The second encounter will define the difference between the control and the intervention group. During this encounter both groups will be provided with a scale, a calibrated bottle, a medication box and a diary. This encounter will differ between the two groups in the following manner: a- The control group, when approached, will be provided with a packed bag of the aforementioned items. No verbal explanation will be provided to the group rather they will be provided with a paper containing the instructions of how to use those items. Both groups will be approached at baseline. The study will be introduced and the participants along with their family caregivers will be consented to participate. Baseline data collection will be done to included: socio-demographic data, social and medical history, physical assessment, laboratory values, discharge medication and frailty scale. Also the translated version of the quality of life questionnaire and that of the self-care of heart failure index will be collected. Patients will then randomized into the control group and the intervention group based on a unique allocated code to each participant. The second encounter will define the difference between the control and the intervention group. During this encounter both groups will be provided with a scale, a calibrated bottle, a medication box and a diary. This encounter will differ between the two groups in the following manner: b- The intervention group: a family conference will take place with the patient and their family carer extending for 60-90 min depending on necessity. This conference will be tailored to their condition, unique symptoms (if present) and subjective demands. The educational session will be structured to include information about heart failure causes, symptoms and management. The latter will comprise a big portion of the educational session focusing on self-management and roles of the family caregiver. Education will include points about salt and fluid restriction, physical activity, symptom recognition, smoking cessation, and adherence to prescribed medication in addition to the aforementioned culture specific practices. Items in the bag will be explained separately emphasising the need to have the medication box filled, with the daily pills according to the prescribed dosages, by the family carer, monitor fluid intake as recommended by their cardiologist with the help of the calibrated bottle used to store the daily fluid allowance, weigh daily after waking up in the morning with light clothes, and documenting the weight in the provided diary. In consultation with their treating cardiologist, a flexible diuretic plan will be implemented. Participants will be instructed to take an extra pill of their diuretic if their weight increases by 1kg over 24 hours or 2kg over 5 days. They will also be advised to contact their cardiologist if weight continues to increase despite the proposed plan. Both groups will be provided with contact details of their cardiologist and the specialist nurse to refer to in case of an emergency. Readmission rates. Timepoint: 30 days. Method of measurement: phone calls. Self-care, QOL, ED presentations, health care utilization and major vascular events. Timepoint: 30 days. Method of measurement: phone calls. UTN: U1111-1163-1944 WHO No sponsor Approved 2013-09-10 University of Technology HREC University of Technology, Sydney, Broadway, Johns strees Sydney NSW Australia