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IRCT20180930041185N1 IRCT 2018-11-03 National Institute for Medical Research Development Effect of the Partnership Care Model in Patients with cerebrovascular accident Evaluation of "Partnership Care Model" on quality of life and activity daily living in Patients' Cerebrovascular accident 2018-11-06 anticipated 80 Complete https://irct.ir/trial/34142 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The allocation of subjects is done by the randomization technique lottery. As 80 cards are numbered for 80 patients and placed in a basket. Then two blank envelopes are determined, one as intervention and one as control. Then, by drawing cards from the basket, some numbers are selected alternately for the two envelopes. Then the patients admitted the hospital receive a number based on their reception order (based on the cards in the pockets), Blinding description: Participants are unaware of the study groups they are allocated to. N/A Stroke / Cerebrovascular Accident. Intervention 1: Intervention group: Patients will receive stroke care and treatment based on partnership care model (PCM). After assessment and recording basic information (demographic variables, care requirements and problems highlighted in the first step of PCM), the care program will prepared and implemented for the intervention group in accordance with the PCM. The program has two phases: (i) an educational partnership meeting; and (ii) a follow-up partnership meeting. In the first phase, at least three educational partnership will be held at the rehabilitation centers weekly; the partnership comprised of 4–6 patients, a nurse and a physician. The nurse will be the leader of the team and the chair of the meetings. The physician will support the patients in decision making. The purpose of these meetings will be motivating and making the patients ready. In the first meeting, the nature, causes and complications of CVA will be introduced to the patients. The second meeting will address non-drug therapy (nutrition and activity regimens). In this meeting, nutrition and activity regimens will be arranged, evaluated and justified for each participant in response to his/her questions, level of distress, condition and status. In the third meeting drug therapy for underlying diseases such as high blood pressure and diabetes will be discussed. Prescription drugs, their effects, their usage and dosage, their importance and side effects will be discussed in addition to address patient's anxiety and answer any questions about the drugs. In the second phase, follow-up partnership meetings will be held monthly in the rehabilitation center for 6 months. These meetings will be held by the partnership of 4–6 patients, the nurse and the physician. The goal of the meetings will be to encourage, support and evaluate the patient compliance and participation during care. At each meeting, in the first 40–45 minutes, blood pressure will be taken and problems with the disease will be considered and addressed, new prescriptions or nutrition regimens will be offered, and previous medical care intervention will be evaluated. The SF-36 & ADL questionnaires are also completed by patients in each session. Intervention 2: Control group: Patients in the control group include stroke patients who receive routine care at the rehabilitation center. These patients are screened and hospitalized at least one month after the attack by the physician.After determining the needs and problems of rehabilitation, physiotherapist or speech therapist referral and rehabilitation is performed, then they are discharged at most after three weeks.They will visited by a researcher at the center. These patients, like the patients in the intervention group, have been visited by a research associate to complete the questionnaires' the quality of life and the Activity of Daily Living at specified intervals. No - There is not a plan to make this available Justification or reason for not sharing IPD is I must provide all information for the sponsoring institution.
public Eesa Mohammadi
Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way
Tehran Iran (Islamic Republic of) 14115-333 +98 21 8288 3585 mohamade@modares.ac.ir Faculty of Medical Sciences, Tarbiat Modares University scientific Eesa Mohammadi
Bridge Nasr (Ghisha), Jalale Al-Ahmad Great Way.
Tehran Iran (Islamic Republic of) 14115-333 +98 21 8288 3585 mohamade@modares.ac.ir Faculty of Medical Sciences of Tarbiat Modares University Iran (Islamic Republic of) Having at least 2 weeks history of treatment for Stroke Being at the age of 60 years old and more Willing to take part in the study Ability of communication and decision making 60 years no limit Both Heart failure (class III , IV) Having malignancies requiring chemotherapy I64 Stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation Intervention group: Patients will receive stroke care and treatment based on partnership care model (PCM). After assessment and recording basic information (demographic variables, care requirements and problems highlighted in the first step of PCM), the care program will prepared and implemented for the intervention group in accordance with the PCM. The program has two phases: (i) an educational partnership meeting; and (ii) a follow-up partnership meeting. In the first phase, at least three educational partnership will be held at the rehabilitation centers weekly; the partnership comprised of 4–6 patients, a nurse and a physician. The nurse will be the leader of the team and the chair of the meetings. The physician will support the patients in decision making. The purpose of these meetings will be motivating and making the patients ready. In the first meeting, the nature, causes and complications of CVA will be introduced to the patients. The second meeting will address non-drug therapy (nutrition and activity regimens). In this meeting, nutrition and activity regimens will be arranged, evaluated and justified for each participant in response to his/her questions, level of distress, condition and status. In the third meeting drug therapy for underlying diseases such as high blood pressure and diabetes will be discussed. Prescription drugs, their effects, their usage and dosage, their importance and side effects will be discussed in addition to address patient's anxiety and answer any questions about the drugs. In the second phase, follow-up partnership meetings will be held monthly in the rehabilitation center for 6 months. These meetings will be held by the partnership of 4–6 patients, the nurse and the physician. The goal of the meetings will be to encourage, support and evaluate the patient compliance and participation during care. At each meeting, in the first 40–45 minutes, blood pressure will be taken and problems with the disease will be considered and addressed, new prescriptions or nutrition regimens will be offered, and previous medical care intervention will be evaluated. The SF-36 & ADL questionnaires are also completed by patients in each session. Control group: Patients in the control group include stroke patients who receive routine care at the rehabilitation center. These patients are screened and hospitalized at least one month after the attack by the physician.After determining the needs and problems of rehabilitation, physiotherapist or speech therapist referral and rehabilitation is performed, then they are discharged at most after three weeks.They will visited by a researcher at the center. These patients, like the patients in the intervention group, have been visited by a research associate to complete the questionnaires' the quality of life and the Activity of Daily Living at specified intervals. Patients' Quality of Life Score based on SF-36 questionnaire. Timepoint: Measurements are done before the intervention, one month after completing the first phase of intervention, and then for up to 6 months, monthly in each follow-up visit. Method of measurement: Short Form- 36 (SF-36) Questionnaires related to quality of life. Activity of Daily Living Score based on The Lawton Criteria. Timepoint: Measurements are done before the intervention, one month after completing the first phase of intervention, and then for up to 6 months, monthly in each follow-up visit. Method of measurement: The Lawton Questionnaire to measure the ٍElderly's Activity of Daily Living. National Institute for Medical Research Development Approved 2018-07-01 University/Regional Research Ethics Committee No. 21, First Besat Ave., West Fathemi Ave. Tehran Tehran Iran (Islamic Republic of)