A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial (Preprint)

BACKGROUND European Society of Cardiology guidelines for the treatment of heart failure (HF) prescribe uptitration of angiotensin-converting enzyme inhibitors (ACE-I) and β-blockers to the maximum-tolerated, evidence-based dose. Although HF prognosis can drastically improve when correctly implementing these guidelines, studies have shown that they are insufficiently implemented in clinical practice. OBJECTIVE The aim of this study was to verify whether supplementing the usual care with the CardioCoach follow-up tool is feasible and safe, and whether the tool is more efficient in implementing the guideline recommendations for β-blocker and ACE-I. METHODS A total of 25 HF patients were randomly assigned to either the usual care control group (n=10) or CardioCoach intervention group (n=15), and observed for 6 months. The CardioCoach follow-up tool is a two-way communication platform with decision support algorithms for semiautomatic remote medication uptitration. Remote monitoring sensors automatically transmit patient’s blood pressure, heart rate, and weight on a daily basis. RESULTS Patients’ satisfaction and adherence for medication intake (10,018/10,825, 92.55%) and vital sign measurements (4504/4758, 94.66%) were excellent. However, the number of technical issues that arose was large, with 831 phone contacts (median 41, IQR 32-65) in total. The semiautomatic remote uptitration was safe, as there were no adverse events and no false positive uptitration proposals. Although no significant differences were found between both groups, a higher number of patients were on guideline-recommended medication dose in both groups compared with previous reports. CONCLUSIONS The CardioCoach follow-up tool for remote uptitration is feasible and safe and was found to be efficient in facilitating information exchange between care providers, with high patient satisfaction and adherence. CLINICALTRIAL ClinicalTrials.gov NCT03294811; https://clinicaltrials.gov/ct2/show/NCT03294811 (Archived by WebCite at http://www.webcitation.org/6xLiWVsgM)

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Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x19899261 ◽

2020 ◽

pp. 1357633X1989926 ◽

Cited By ~ 1

Author(s):

Lucía M Yanicelli ◽

Carla B Goy ◽

Viviana del C González ◽

Gerardo N Palacios ◽

Ernesto C Martínez ◽

...

Keyword(s):

Heart Failure ◽

Clinical Trial ◽

Usual Care ◽

Treatment Adherence ◽

Intervention Group ◽

Self Care ◽

Control Group ◽

Heart Failure Patients ◽

Home Telemonitoring

Introduction The low quality of life in heart failure patients is related to low self-care and treatment adherence. Consequently, innovative strategies are needed to improve them. The objective of this work is to determine the effectiveness of the use of a home telemonitoring system to improve the self-care and treatment adherence of heart failure patients. Methods A randomized clinical trial that compares the efficacy of a home telemonitoring system –intervention group versus usual care control group – among heart failure outpatients over a 90-day monitoring period was carried out. The home telemonitoring system consists of an application that collects measurements of different parameters on a daily basis and provides health education to patients. The home telemonitoring system processes data gathered and generates an alert if a risky situation arises. The outcomes observed were significant changes in patients’ self-care (European Heart Failure Self-care Behaviour Scale), treatment adherence (Morisky Modified Scale) and re-hospitalizations over the follow-up period. Results 104 heart failure patients were screened; 40 met the inclusion criteria; only 30 completed the study. After the follow-up, intragroup analysis of the control group indicated a decrease in treatment adherence ( p = 0.02). The mean European Heart Failure Self-care Behaviour Scale overall score indicated an improved self-care in the intervention group patients ( p = 0.03) and a worsened self-care in the control group ( p = 0.04) with a p value of 0.004 in the intergroup analysis. Thanks to the home telemonitoring system alerts, two re-hospitalizations were avoided. Discussion This study demonstrated that the proposed home telemonitoring system improves patient self-care when compared to usual care and has the potential to avoid re-hospitalizations, even considering patients with low literacy levels. Trial Registration: Home Telemonitoring System for Patients with Heart Failure. clinicaltrials.gov Identifier: NCT04071093

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Effect of a Structured Pharmaceutical Care Intervention Versus Usual Care on Cardiovascular Risk in HIV Patients on Antiretroviral Therapy: INFAMERICA Study

Annals of Pharmacotherapy ◽

10.1177/1060028018778045 ◽

2018 ◽

Vol 52 (11) ◽

pp. 1098-1108 ◽

Cited By ~ 3

Author(s):

Ramón Morillo-Verdugo ◽

María de las Aguas Robustillo-Cortés ◽

María Teresa Martín-Conde ◽

Gador Callejón-Callejón ◽

Purificación Cid-Silva ◽

...

Keyword(s):

Cardiovascular Risk ◽

Usual Care ◽

Pharmaceutical Care ◽

Intervention Group ◽

Text Messages ◽

Control Group ◽

Framingham Score ◽

Hiv Patients ◽

Number Of Patients

Background: HIV+ patients have increased their life expectancy with a parallel increase in age-associated comorbidities. Objective: To determine the effectiveness of an intensive pharmaceutical care follow-up program in comparison to a traditional model among HIV-infected patients with moderate/high cardiovascular risk. Method: This was a multicenter, prospective, randomized study of a structured health intervention conducted between January-2014 and June-2015 with 12 months of follow-up at outpatient pharmacy services. The selected patients were randomized to a control group (usual care) or intervention group (intensive pharmaceutical care). The interventional program included follow-up of all medication taken by the patient to detect and work toward the achievement of pharmacotherapeutic objectives related to cardiovascular risk and making recommendations for improving diet, exercising, and smoking cessation. Individual motivational interview and periodic contact by text messages about health promotion were used. The primary end point was the percentage of patients who had reduced the cardiovascular risk index, according to the Framingham-score. Results: A total of 53 patients were included. As regards the main variable, 20.7% of patients reduced their Framingham-score from high/very high to moderate/low cardiovascular risk versus 12.5% in the control group ( P=0.016). In the intervention group, the number of patients with controlled blood pressure increased by 32.1% ( P=0.012); 37.9% of patients overall stopped smoking ( P=0.001), and concomitant medication adherence increased by 39.4% at the 48-week follow-up ( P=0.002). Conclusion and Relevance: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies might lead to improved health outcomes in HIV+ patients at greater cardiovascular risk.

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Abstract T MP103: Effect of Follow-up Phone Calls on 30-day Readmission Rates for Stroke Patients

Stroke ◽

10.1161/str.46.suppl_1.tmp103 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Kelly Anderson

Keyword(s):

Intervention Group ◽

Signs And Symptoms ◽

Lifestyle Changes ◽

Phone Call ◽

Control Group ◽

Readmission Rates ◽

Convenience Sample ◽

Phone Calls ◽

Number Of Patients

Background and Purpose: Patients who are hospitalized for a stroke or TIA go home with a great deal of information about risk factors, medications, diet and exercise, signs and symptoms of stroke and follow-up care. This information may be difficult for the patient or caregiver to understand and can be overwhelming in the face of a new life-changing event. In addition, The Centers for Medicare and Medicaid Services will start publicly reporting 30-day readmission rates beginning in 2016. The purpose of this study is to determine if follow-up phone calls with a nurse help to reduce 30 day readmission rates for patients with stroke and TIA. Methods: This study utilized a convenience sample of adult patients who were admitted for ischemic stroke, ICH, SAH or TIA from March 2013 to February 2014. Patients in the intervention group participated in a phone call seven days after discharge to assess their compliance with medications, physician appointments and lifestyle changes. The proportion of readmissions between the groups was compared with Fisher’s exact test. Results: The total number of patients enrolled in the study was 586 and there were no significant differences in demographics between the control and intervention groups. Of the 533 patients in the control group, 54 (10%) of them were readmitted, including 11 patients readmitted for elective surgical procedures. Of the 52 patients in the intervention group, 3 (5.7%) of them were readmitted before the 7-day phone call. Of the 49 patients who participated in the 7-day phone call, none of them were readmitted ( p =0.0098). Conclusions: Patients who participate in a 7-day phone call appear to benefit and are less likely to be readmitted to the hospital. Other strategies may need to be considered for patients who are at higher risk, and thus more likely to be readmitted within seven days of discharge. In addition, some providers may wish to reconsider how they schedule elective procedures for secondary stroke prevention.

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Abstract 225: A Depression Quality Program and Cardiovascular Disease: Assessing the Impact on Care

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.10.suppl_3.225 ◽

2017 ◽

Vol 10 (suppl_3) ◽

Author(s):

Linda Gordon ◽

Amanda Malecky ◽

Andrew Althouse ◽

Nicole Ansani

Keyword(s):

Usual Care ◽

Goal Attainment ◽

Intervention Group ◽

Phone Call ◽

Categorical Variables ◽

Care Group ◽

Control Group ◽

Surrogate Outcome ◽

The Impact

Background: Data demonstrate an adverse association between depression and coronary artery disease prognosis. Therefore, a depression screening program was initiated in the catheterization (cath) lab. The goals were to improve HEDIS depression compliance rates and determine the impact on clinical outcomes. Methods: Adult patients in an inpatient cath lab from 3 cardiology practices were screened for enrollment in a randomized controlled trial. All cath lab patients received a PHQ-9 depression screener. Those who screened positive for depression (score ≥ 10) were randomized to intervention or usual care. The usual care group received a follow-up phone call to re-administer the PHQ-9 at 6-8 weeks and within 210 days of discharge. The intervention group was administered the PHQ-9 and received intensive education at baseline, 6-8 weeks, and within 210 days of discharge. Education included targeted depression information with a mental health care provider and comprehensive disease management education with a cardiovascular nurse practitioner. Outcomes included: differences in HEDIS depression goal attainment; depression response/remission rates; and cardiovascular goals. Differences between groups were tested using chi-squared tests (categorical variables) and t-tests (continuous variables). Results: Baseline characteristics were similar between control (N=43) and intervention (N=40) groups, with the exception of significantly fewer African American patients in the control group (N=2, 4.7%) vs intervention (N=9, 22.5%). Changes in HEDIS goal attainment show that patients in the intervention group were slightly more likely to be referred to a provider to address depression (95.0% vs 86.0%, p=0.314), or receive meds for depression (65.0% vs 51.2%, p=0.219), but these differences are not statistically significant. More patients in the intervention group refused meds for depression compared to control (15.0% vs. 2.3%, p=0.041); have received blood work (65.0% vs 41.9%, p=0.030); and have received follow-up within 210 days (82.5% vs 46.5%, p<0.001). Treatment adjustment rate was higher in the intervention group compared to control (85.0% vs. 65.1%, p=0.037). Hospital readmission rate was similar between groups (p=0.896) and there was no difference in depression remission or response rates (p=0.426). Further, no differences were seen in cardiovascular surrogate outcome parameters, including cholesterol, A1c, CRP, or BNP between groups; except SGOT was significantly different between groups (-5.0 intervention vs 2.0 control p=0.045). Conclusions: These data demonstrate improvements in attaining a surrogate outcome measure of quality (HEDIS goals); however, this does not appear to translate to a significant clinical impact. Quality measures may need to be continuously reassessed to ensure efficiency and effectiveness of care.

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An improvement in self-care behaviour in heart failure patients lead to better management of hypertension

European Heart Journal ◽

10.1093/ehjci/ehaa946.1127 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

D.S Sahlin ◽

S Gerward

Keyword(s):

Heart Failure ◽

Mean Arterial Pressure ◽

Arterial Pressure ◽

Controlled Trial ◽

Intervention Group ◽

Self Care ◽

Control Group ◽

Chi Square ◽

Home Based ◽

Number Of Patients

Abstract Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg < MAP <100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP >100 mmHg, with 22% in the CG versus 16% in the IG having MAP >100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None

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A Children’s Asthma Education Program: Roaring Adventures of Puff (RAP), Improves Quality of Life

Canadian Respiratory Journal ◽

10.1155/2010/327650 ◽

2010 ◽

Vol 17 (2) ◽

pp. 67-73 ◽

Cited By ~ 27

Author(s):

Shawna L McGhan ◽

Eric Wong ◽

Heather M Sharpe ◽

Patrick A Hessel ◽

Puish Mandhane ◽

...

Keyword(s):

Quality Of Life ◽

Usual Care ◽

Education Program ◽

Intervention Group ◽

Asthma Management ◽

Control Group ◽

Asthma Education ◽

Children With Asthma

BACKGROUND: It is postulated that children with asthma who receive an interactive, comprehensive education program would improve their quality of life, asthma management and asthma control compared with children receiving usual care.OBJECTIVE: To assess the feasibility and impact of ‘Roaring Adventures of Puff’ (RAP), a six-week childhood asthma education program administered by health professionals in schools.METHODS: Thirty-four schools from three health regions in Alberta were randomly assigned to receive either the RAP asthma program (intervention group) or usual care (control group). Baseline measurements from parent and child were taken before the intervention, and at six and 12 months.RESULTS: The intervention group had more smoke exposure at baseline. Participants lost to follow-up had more asthma symptoms. Improvements were significantly greater in the RAP intervention group from baseline to six months than in the control group in terms of parent’s perceived understanding and ability to cope with and control asthma, and overall quality of life (P<0.05). On follow-up, doctor visits were reduced in the control group.CONCLUSION: A multilevel, comprehensive, school-based asthma program is feasible, and modestly improved asthma management and quality of life outcomes. An interactive group education program offered to children with asthma at their school has merit as a practical, cost-effective, peer-supportive approach to improve health outcomes.

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Early rehabilitation after hospital admission for road trauma using an in-reach multidisciplinary team: a randomised controlled trial

Clinical Rehabilitation ◽

10.1177/0269215517694462 ◽

2017 ◽

Vol 31 (9) ◽

pp. 1189-1200 ◽

Cited By ~ 4

Author(s):

Jane Wu ◽

Steven G Faux ◽

John Estell ◽

Stephen Wilson ◽

Ian Harris ◽

...

Keyword(s):

Length Of Stay ◽

Usual Care ◽

Intervention Group ◽

Psychological Status ◽

Randomised Control Trial ◽

Control Group ◽

Rehabilitation Team ◽

Secondary Outcomes ◽

The Impact

Objective: To investigate the impact of an in-reach rehabilitation team for patients admitted after road trauma. Design: Randomised control trial of usual care versus early involvement of in-reach rehabilitation team. Telephone follow-up was conducted by a blind assessor at three months for those with minor/moderate injuries and six months for serious/severe injuries. Setting: Four participating trauma services in New South Wales, Australia. Subjects: A total of 214 patients admitted during 2012-2015 with a length of stay of at least five days. Intervention: Provision of rehabilitation services in parallel with ward based therapy using an in-reach team for the intervention group. The control group could still access the ward based therapy (usual care). Main measures: The primary outcome was acute length of stay. Secondary outcomes included percentage requiring inpatient rehabilitation, function (Functional Independence Measure and Timed Up and Go Test), psychological status (Depression Anxiety and Stress Score 21), pain (Orebro Musculoskeletal Pain Questionnaire) and quality of life (Short Form-12 v2). Results: Median length of stay in acute care was 13 days (IQR 8-21). The intervention group, compared to the control group, received more physiotherapy and occupational therapy sessions (median number of sessions 16.0 versus 11.5, P=0.003). However, acute length of stay did not differ between the intervention and control groups (median 15 vs 12 days, P=0.37). There were no significant differences observed in the secondary outcomes at hospital discharge and follow-up. Conclusion: No additional benefit was found from the routine use of acute rehabilitation teams for trauma patients over and above usual care.

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Abstract 18944: Efficacy of Clinical Notifications to Health Care Providers in Management of Heart Failure Patients

Circulation ◽

10.1161/circ.132.suppl_3.18944 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Reyhaneh M Akhavein ◽

Jiri Sklenar ◽

Jessica Minnier ◽

Stephen Heitner

Keyword(s):

Heart Failure ◽

Health Care Providers ◽

Anticoagulation Therapy ◽

Intervention Group ◽

Direct Result ◽

Control Group ◽

Evidence Based ◽

Written Communication ◽

Care Providers ◽

Provider Behavior

Introduction: Adherence to guideline recommendations for patients with heart failure improves short and long-term outcomes, and can potentially reduce healthcare costs. Hypothesis: Written communication to care providers of individuals with heart failure with reduced systolic function (HFrEF) will result in better adherence to guidelines. Methods: We prospectively enrolled providers of all outpatients with HFrEF at Oregon Health and Science University in 2012. We reviewed adherence to six evidence-based HF therapies in each patient [ACE-I/ARB, beta blocker, aldosterone antagonist, anticoagulation therapy for atrial fibrillation or flutter, CRT, and ICD]. We excluded patients with destination therapy, resolution of HFrEF, lost to follow-up or death. After implementation of exclusion criteria, of 320 patients evaluated, 114 patients were ultimately included. These patients’ providers were randomized to either receiving a standardized written communication (intervention) or none (control). The letter highlighted 2013 ACCF/AHA heart failure management guidelines, and was sent by US mail to providers in intervention group. Six months later, we re-evaluated all patients according to the same criteria at the outset. Results: Optimal medical therapy (OMT) in intervention group improved in only 9% of patients who were previously sub-optimally treated (p 0.83), but 31% of patients who had already been on OMT experienced deescalated therapies despite no clear documentation (p 0.65). In control group, 11% of patients had increased treatment according to guidelines, and 9% of patients who had already been receiving OMT had deescalated treatment. There were no new ICDs implanted as a result of intervention, while 6.5% of patients in control group did receive ICD (p 0.46). Conclusions: Identification of patients with HFrEF and assessment of adherence to guideline-based therapies is now feasible via electronic medical record enquiry. Written notifications do not result in improved adherence to evidence-based guidelines, nor do these letters seem to alter provider behavior at all. We speculated that the lack of response is a direct result of “notification-fatigue”, and that alternative provider behavior modification techniques need to be evaluated.

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Peer mentorship to improve self-management of hip and knee osteoarthritis: a randomised feasibility trial

BMJ Open ◽

10.1136/bmjopen-2020-045389 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045389

Author(s):

Anna M Anderson ◽

Elizabeth C Lavender ◽

Esther Dusabe-Richards ◽

Teumzghi F Mebrahtu ◽

Linda McGowan ◽

...

Keyword(s):

Usual Care ◽

Sample Size ◽

Intervention Group ◽

Feasibility Trial ◽

Self Management ◽

Control Group ◽

Peer Mentor ◽

Peer Mentorship ◽

Knee Oa ◽

Patient Reported

ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.

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The Effect of Teaching Palliative Care on the Self-Efficacy of Elderly Patients with Chronic Heart Failure

Revista del Cuerpo Médico del HNAAA ◽

10.35434/rcmhnaaa.2019.123.530 ◽

2020 ◽

Vol 12 (3) ◽

pp. 201-207

Author(s):

Mahnaz Modanloo ◽

Ameneh Tazikeh-Lemeski ◽

Shohreh Kolagari

Keyword(s):

Heart Failure ◽

Palliative Care ◽

Chronic Heart Failure ◽

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Significant Difference ◽

The Mean ◽

And Control

ABSTRACTObjetive: Determine the effect of teaching palliative care on the self-efficacy of elderly with Chronic Heart Failure. Material and Methods: This single-blind randomized clinical trial was done on patients with Chronic Heart Failure attending to the heart clinics of Golestan University of Medical Sciences in 2018. 48 eligible patients with class-III were selected via convenience sampling. Patients allocated into control and intervention group randomly (n=32). Palliative care training was done for intervention group for six weeks. Data was gathered through the Cardiac Self-Efficacy Scale (CSES) on three time points (before, immediately, and one month after intervention). Data were analyzed in SPSS-18 using independent t-test, chi-squared, Fisher's exact, and repeated-measures ANOVA with corrected Bonferroni post-hoc test. Results: Finding showed that before intervention the mean scores of self-efficacy in intervention and control group was 23.95±8.34 and 24.11±9.41, respectively. Immediate and one month after intervention it was 26.30±8.30 vs. 28.95±8.53 in intervention group and 24.68±9.32 vs. 25.53±10.39 in control group. In intervention group there was no significant difference between the mean scores of before with immediate and one month after intervention. However, there was a significant difference between the two time follow up in both intervention (p<0.0001) and control (p<0.003) groups. Conclusion: Although the education of palliative care has increased the ability to care in elderly, it seems that self-managing in complex conditions is required follow-up over time.

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