Psychometric evaluation of the Connor-Davidson Resilience Scale among Iranian population.

BACKGROUND: The resilience construct is considered a personal trait composed of multiple aspects. Connor-Davidson Resilience Scale is a standard tool composed of five factors and 25 items. This study aimed to determine the psychometric properties of this scale. METHODS: In this cross-sectional study, after the scale translation, the factorial structural validity was assessed via the confirmatory factor analysis with 70 180 samples. Internal consistency, composite reliability, convergent validity were assessed by calculating Cronbach's alpha, composite reliability, maximum reliability, and Average Variance Extracted. The discriminant validity was assessed using Heterotrait-monotrait ratio of correlations matrix and also, measure invariance was evaluated. RESULTS: The original five-factor model had good model fit indices but due to low factor loading of item 2 and 20, the model was modified. The Cronbach's alpha and composite reliability for four factors were above 0.7 (except for factor 5). The convergent validity for all five factors were achieved. Between factors 1 with 2 and 4, 2 with 3 and 4 discriminant validity was not established (correlations > 0.9) and the results suggested that there might be a second-order latent construct behind these factors. Therefore, a second-order assessment was performed. The results of the second-order latent construct assessment showed a good goodness-of fit and strong measurement invariance for both men and women. CONCLUSION: The 23-item version of Connor-Davidson Resilience Scale is a reliable and valid scale to measure resilience as a complex construct in the Iran context.

Development and validation of care stress management scale in family caregivers for people with Alzheimer: a sequential-exploratory mixed-method study.

BACKGROUND: Caring for a person with Alzheimer's disease is stressful for caregivers. So that, considering all the emotional and financial costs imposed on the families of Alzheimer's patients, stress from caring is an issue that cannot be ignored and plans need to be developed to help these caregivers to manage the care properly. The current study was designed to develop a valid and reliable care stress management scale for family caregivers of patients with Alzheimer's. METHODS: This study is a methodological study with a sequential-exploratory mixed-method approach that was performed in two-phase: develop the caring stress management scale and evaluate the psychometric properties of the scale. In the first phase, 14 semi-structured face-to-face interviews were performed with family caregivers of patients with Alzheimer's. The interviews were transcribed immediately and an item pool with 275 items was prepared. After removing the duplicate or overlapping code, the initial format of the caring stress management scale (CSMS) was designed. In the second step, the items of the CSMS were evaluated using face and content validity. After that, the construct validity was evaluated using exploratory factor analysis, confirmatory factor analysis, and convergent and divergent validity respectively. Finally, the reliability was assessed by stability and internal consistency. The sample size was 435 and data was gathered via an online form questionnaire. RESULTS: This study designed the CSMS with two factors including emotional-focused coping (4 items) and problem-focused coping (4 items) that explained 51.00% of the total variance. The results of the confirmatory factor analysis showed a good model fit. Furthermore, the internal consistency and stability of this scale were acceptable. CONCLUSION: The results showed that the care stress management scale has two factors in Iranian family caregivers and it is valid and reliable and can be used by therapists and researchers.

Cross-Cultural Evaluation of the Psychometric Properties of the Spiritual Well-Being Scale: A Systematic Review.

Since spiritual well-being has a significant role in individual and social health, using a valid scale to identify these properties is essential. Comparing factor structure and differences in the number of dimensions and items of subscales could be an indicator of differences in individuals' attitudes toward spirituality among diverse cultures. The present review was performed for psychometric evaluation of the spiritual well-being measures. A systematic review of international databases and Iranian databases was conducted to evaluate studies published between January 1, 1970, and October 1, 2022. QUADAS-2, STARD, and COSMIN scales were used for risk of bias assessment. Following two rounds of screening, 14 articles entered quality assessment. According to the results, studies examining the factor structure of the spiritual well-being scale (SWBS) instrument have been conducted for the years 1998 to 2022. The mean age of the participants in these studies ranged from 20.8 to 79.08 years. During the process of exploratory factor analysis, the researchers reported the presence of two to five latent factors, and the range of explained variance was between 35.6 and 71.4%. However, most of the reports indicated the existence of two or three latent factors. The findings of the present study provide an image of the psychometric status of the SWBS for researchers and clinicians in this field and can help them make optimum decisions in selecting a scale or conducting additional psychometric studies or adopting this scale for studies in new populations.

A time-series prediction model of acute myocardial infarction in northern of Iran: the risk of climate change and religious mourning.

BACKGROUND: Although various studies have been conducted on the effects of seasonal climate changes or emotional variables on the risk of AMI, many of them have limitations to determine the predictable model. The currents study is conducted to assess the effects of meteorological and emotional variables on the incidence and epidemiological occurrence of acute myocardial infarction (AMI) in Sari (capital of Mazandaran, Iran) during 2011-2018. METHODS: In this study, a time series analysis was used to determine the variation of variables over time. All series were seasonally adjusted and Poisson regression analysis was performed. In the analysis of meteorological data and emotional distress due to religious mourning events, the best results were obtained by autoregressive moving average (ARMA) (5,5) model. RESULTS: It was determined that average temperature, sunshine, and rain variables had a significant effect on death. A total of 2375 AMI's were enrolled. Average temperate (°C) and sunshine hours a day (h/day) had a statistically significant relationship with the number of AMI's (ß = 0.011, P = 0.014). For every extra degree of temperature increase, the risk of AMI rose [OR = 1.011 (95%CI 1.00, 1.02)]. For every extra hour of sunshine, a day a statistically significant increase [OR = 1.02 (95% CI 1.01, 1.04)] in AMI risk occurred (ß = 0.025, P = 0.001). Religious mourning events increase the risk of AMI 1.05 times more. The other independent variables have no significant effects on AMI's (P > 0.05). CONCLUSION: Results demonstrate that sunshine hours and the average temperature had a significant effect on the risk of AMI. Moreover, emotional distress due to religious morning events increases AMI. More specific research on this topic is recommended.

Psychometrics of Persian version of the 11 items De Jong Gierveld loneliness scale among an Iranian older adults population.

BACKGROUND: Older adults duo to circumstances of aging such as relationship losses, medical morbidities, and functional declines, are prone to social isolation and loneliness more than any other age group. Furthermore, with The recent outbreak of the COVID-19 pandemic and the need to quarantine, the possibility of feelings of loneliness, especially in older adults, became an important nursing priority. Therefore, it is important to quickly identify loneliness and respond appropriately to prevent, reduce, or treat it. The aim of this study was to translate the De Jong Gierveld loneliness scale into Persian for older adults. METHODS: The sample was 400 adults aged 65 and older with a mean age of 71.32 (SD= ± 6.09) years. Recruitment and data collection was done via online methods. The original scale was translated into Persian using the World Health Organization (WHO) protocol of forward-backward translation technique. Face validity and content validity; was followed by exploratory and confirmatory factor analysis. Lastly, reliability was assessed using the Average Inter-Item Correlation, Cronbach's alpha, and McDonald's Omega. RESULTS: The results showed that the Persian version of the loneliness scale had two factors namely social loneliness (5 items) and emotional loneliness (3 items) and the combined score explained 45.66% of the total variance of this scale. In addition, all goodness of fit indices confirmed a two factors model fit and all of the reliability indices were excellent. CONCLUSIONS: The Persian version of the loneliness scale is useful and suitable for detecting social loneliness and emotional loneliness in older Iranian adults.

The Lived Experience of Jordanian Parents of Children with Cystic Fibrosis: Qualitative Study.

BACKGROUND: Cystic fibrosis (CF) is a common autosomal recessive disease with an incidence of 1:2560 live births in Jordan. It affects the quality of life for both the child and the parents. In Jordan knowledge about parents' experience with children diagnosed with CF is limited. PURPOSE: The purpose of this study was to describe and explore the lived experience of parents of children with CF, and the difficulties and challenges they face. DESIGN AND METHOD: A qualitative phenomenological method was used. Twenty-five parents of children with CF were interviewed. The Scribber thematic analysis was used in data analysis. RESULTS: Four themes emerged. First, "Falling into the circle of suffering", Second, "The circle of suffering", with two sub-themes: the challenges, and the limitations in daily life. Third, "Coping within the circle of suffering", with four sub-themes: focus on problems, focus on emotions, social and economic factors, and spirituality. Fourth, "Future outlook", with two sub-themes: optimism about the future, and pessimism about the future. CONCLUSION: Parents of children with CF suffer from difficulties and challenges that limit their daily lives. PRACTICE IMPLICATIONS: Education is needed for health care providers, society and parents about CF; and parents need support to improve their quality of life.

Resilience in Iranian adolescents during the COVID-19 pandemic: Psychometric Evaluation of the Connor-Davidson Resilience Scale.

Background: Resilience is a measure of the ability to cope with stress and the accurate measurement of it is critical. This study aimed to translate and evaluate the psychometric properties of the Connor-Davidson Resilience Scale in Iranian adolescents during the Coronavirus Disease (COVID-19) pandemic.Methods: In this cross-sectional study, after the scale translation, the content and construct validity were assessed using exploratory and confirmatory factor analysis. Moreover, internal consistency, composite reliability, and invariance measurement were evaluated.Results: The content validity ratio was greater than 0.49, and the modified kappa coefficient for all items was higher than 0.6. With exploratory factor analysis, two factors were extracted consisting of 16 items and explaining 43% of the total variance. The results of confirmatory factor analysis indicated a good fit for the model. Cronbach's alpha and composite reliability for both factors were greater than 0.7. Although there is no significant difference (p = 0.09) in the average resilience of adolescents in different provinces, boys (42.64 ± 10.90) had a significantly (p < 0.001) higher resilience score than girls (40.10 ± 11.92).Conclusion: The study results showed that the Persian 16-item version of the Connor-Davidson Resilience Scale has acceptable reliability and validity in the Iranian adolescent population.

Psychometric Evaluation of the Persian Version of Religious Orientation Scale in Iranian Patients with Cancer.

This paper reports on the psychometric properties of the Religious Orientation Scale (ROS) with a sample of 311 Iranian patients who were suffering from cancer between September and December 2020. A cross-sectional study design was used, and convenience sampling was employed. Reliability was evaluated by internal consistency Cronbach's alpha, McDonald's omega, and average inter-item correlation. The exploratory factor analysis showed that the ROS had 15 items and two factors (religious identity and personal identity) that explained 43.2% of the total variance of religious orientation in Iranian patients with cancer. Construct validity was assessed by means of confirmatory factor analysis. The internal consistency and composite reliability were acceptable. The results indicate that the ROS can produce reliable and valid data on religious orientation in a sample of Iranian patient with cancer.

Effectiveness of a telephone delivered and a face-to-face delivered counseling intervention for smoking cessation in patients with coronary heart disease: a 6-month follow-up.

Smoking cessation interventions for cardiac patients need improvement given their weak effects on long-term abstinence rates and low compliance by nurses to implementation. This study tested the effectiveness of two smoking cessation interventions against usual care in cardiac patients, and conditional effects for patients' motivation to quit and socio-economic status (SES). An experimental study was conducted from 2009 to 2012 for which Dutch cardiac patient smokers were assigned to: usual care (UC; n = 245), telephone counseling (TC; n = 223) or face-to-face counseling (FC; n = 157). The three groups were comparable at baseline and had smoked on average 21 cigarettes a day before hospitalization. After six months, interviews occurred to assess self-reported smoking status. Patients in the TC and FC group had significantly higher smoking abstinence rates than patients in the UC group (p ≤ 0.05 at all times). Regression analysis further revealed significant conditional effects of the interventions on smoking abstinence in patients with lower SES, with a larger effect for TC than FC when compared to UC. These findings suggest that intensive counseling is effective in increasing short-term abstinence rates, particularly in patients with lower SES. Future studies need to investigate how patients with higher SES can profit equally from these type of interventions.

Predictors of non-adherence to follow-up visits and deferasirox chelation therapy among jordanian adolescents with Thalassemia major.

Poor adherence to treatment can have negative effects on outcomes and heath care cost. However, little is known about the factors that impact adherence to deferasirox chelation therapy. The aims of this study were to identify rates and predictors of non-adherence to medical regimen among thalassemia major adolescents on deferasirox oral chelation therapy by using subjective (self-reporting) and objective (serum ferritin and follow-up visits) measures. Convenient samples of 164 adolescents, aged 12-19 years were recruited from three National Thalassemia Centers in Jordan. Patients were interviewed using a four-section questionnaire and the medical records were checked. Results indicated that rate of adherence according to self-report was (73%); while to follow-up medical appointments and serum ferritin level rates was 57% and 47%, respectively. One-third of participant adolescents (n = 52) were psychologically impaired. Multivariate analysis showed that factors affecting adolescent non-adherence to deferasirox chelation therapy is different from that affecting adherence to follow-up visits. In general, adolescents more than 16 years old, presence of sibling with thalassemia, lack of parental monitoring, lower family income, decrease frequency of blood transfusion, and psychological impairment were found significant predictors of non-adherence among adolescents. Disease knowledge was not associated with adherence status of the adolescents. Clinician should be aware of high prevalence of low adherence to chelation therapy during adolescent years. Nurses need to regularly assess, monitor, and promote adherence behavior that might impact patients' outcomes.

Impact of psychosocial status and disease knowledge on deferoxamine adherence among thalassaemia major adolescents.

This cross-sectional study aimed to explore the relationship between psychosocial status, disease knowledge and adherence to deferoxamine treatment in adolescents with thalassaemia major. A purposive sample of 36 adolescents with transfusion dependence, ages 12-19 years, was recruited. A semi-structured interview and two structured questionnaires were used. In this sample, 56% were low adherence and 36% were psychologically impaired. Statistically significant factors associated with psychological impairment were: adolescents more than 16 years; low deferoxamine adherence; mean ferritin more than 2500 µg/L; family size more than six; family income equal or less than 350 Jordanian dinar and having sibling with thalassaemia. Additionally, adolescents with high level of knowledge had significantly lower scores on Pediatric Symptom Checklist.

Effectiveness of a resilience-focused educational program for promoting resilience in nursing students: A systematic review and meta-analysis.

AIM: To evaluate the effectiveness of a resilience-focused educational program to promote resilience among the forming year's BSN students. BACKGROUND: Resilience is a resource for the well-being and growth of nursing students. Lack of resilience is a high-risk condition for psychosocial health problems that hinder students' academic and professional growth during the BSN program. DESIGN: A systematic review and meta-analysis are reported using PRISMA guidelines. The review was registered at the PROSPERO with the ID number: CRD42023475098. METHODS: A primary search was done on the most relevant databases: PubMed, CINAHL, and PsycINFO while a secondary search was done on the Wiley Online Library, HEC Digital Library, and Science Direct for studies in the English language that assessed resilience-building interventions in forming years (1st and 2nd year) undergraduate nursing students till Oct 2023. Both quasi-experimental studies (QESs) and randomized control trial studies (RCTs) were included in this review. The meta-analysis was performed on three QESs and two RCTs that provided information about a pooled estimate of resilience promotion. RESULTS: Of 596 identified records, six were found eligible comprising four QESs and two RCTs with a total of 472 participants. Studies were found with variability in sample size, intervention strategy, teaching-learning activities, intervention content and duration, measurement scales, and statistical analysis of the main outcome. Meta-analysis of QESs showed no effects between pre-and post-intervention resilience scores, the standardized mean difference (SMD) of 0.04 [95 % CI -0.22, 0.30]. The RCTs immediately after intervention showed a non-significant effect, SMD 0.35 [95 % CI -0.06, 0.75]; however, at follow-up of one month, it showed a statistically significant effect in favor of the experimental group, SMD 0.54 [95 % CI 0.12, 0.95]. CONCLUSION: This review has provided evidence of a delayed effect of educational intervention to improve resilience among nursing students. The resilience-focused educational intervention has the potential to improve the resilience of nursing students. However, because of the time-bound and multi-faceted nature of resilience, a need to develop an inclusive multi-dimensional approach for resilience building is recommended for future studies. REPORTING METHOD: The manuscript has been written in adherence with PRISMA guidelines for the systematic review and meta-analysis.

Assessing the validity and reliability of the 10-item Persian version of the perceived stress scale in post-surgery patients.

Introduction: The 10-item Perceived Stress Scale (PSS-10) is commonly used to measure stress levels in postoperative patients, as research shows that high levels of stress can affect postoperative outcomes. By using the PSS-10, healthcare providers can understand patients' psychological well-being before and after surgery, helping improve recovery and overall health. This study focuses on assessing the reliability and validity of the 10-item Persian version of the PSS (PSS-10-P) in postoperative patients. Methods: In a methodological study conducted between October to December 2023, a sample of 400 patients who had undergone surgery in 17 Shahrivar Hospital, Amol, Iran were selected using a convenience sampling method. The PSS-10 scale utilized in the study was translated, and its psychometric properties were evaluated through assessments of construct validity, including exploratory (n = 200) and confirmatory (n = 200) factor analysis, convergent validity, and discriminant validity. Furthermore, the study examined the internal consistency of the scale to ensure its reliability. Results: The mean age of the participants was 44.38 (SD= 13.49) years. The results of exploratory factor analysis with Promax rotation extracted two factors accounting for 83.82% of the variance comprising 10 items. After necessary modifications during CFA, the final model was approved. As for reliability, the Cronbach's alpha, CR, and MaxR for all constructs were greater than 0.7, demonstrating good internal consistency and construct reliability. Conclusion: According to these results, the Persian version of PSS-10 has a valid structure and acceptable reliability. This scale can be used by health professionals in many ways.

Efficacy of Polyunsaturated Fatty Acids as a Treatment for Post-traumatic Stress Disorder: A Systematic Review.

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a prevalent health condition among members of the military. Although the efficacy of pharmacological and psychiatric interventions for PTSD has been well studied, there are limited data on the effects of omega-3 (n-3) polyunsaturated fatty acid (PUFA) interventions on PTSD. The use of PUFAs shows promise because of their neuroprotective effects. Thus, this systematic review will synthesize the current state of the evidence regarding the effectiveness of PUFA treatment for PTSD. MATERIALS AND METHODS: Using the PubMed, PsychINFO, Embase, and CINAHL databases, a search of the literature was conducted using the search terms "posttraumatic-stress-disorder, combat disorders, trauma-related-stress-disorder, omega-3, fatty acid, and polyunsaturated fatty acids" to identify articles published from January 1, 2008, to January 1, 2024, that focused on PUFA interventions for PTSD. A total of 281 articles were identified. Following exclusions and quality assessments using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria proposed by Cochrane, 6 randomized controlled trials (RCTs) and preclinical studies were chosen for inclusion, and data were then extracted into a data matrix for final synthesis and analysis. RESULTS: The RCTs (n = 3) showed no significant effect of PUFAs in the prevention of PTSD symptom onset. Among preclinical studies (n = 3), PUFAs resulted in a significant decrease in anxiety-like behavior and fear memory and an increase in spatial learning and memory. The quality of evidence among the 6 RCTs and preclinical studies using the Cochrane GRADE criteria ranged from low to high. CONCLUSIONS: The results from this systematic review suggest that more evidence is needed before making any recommendations for the clinical use of dietary PUFAs in the management of PTSD symptoms.

Prevalence of PTSD in Active Duty Members with Mild Traumatic Brain Injury: Systematic Review and Meta-analysis.

INTRODUCTION: Traumatic brain injury (TBI), particularly mild TBI (mTBI), is a significant health concern for U.S. active duty service members (ADSMs), with potential implications for psychiatric outcomes including PTSD. Despite recognizing this association, the prevalence of PTSD among ADSMs with mTBI remains unclear. MATERIALS AND METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A thorough search in PubMed, CINAHL, Embase, and PsycINFO databases from 2008 to 2024 focused on identifying studies involving ADSMs with PTSD and mTBI. The R software (version 4.3.2) was employed for meta-analysis with the "meta" and "meta prop" packages. RESULTS: Eight reviewed studies revealed a pooled prevalence estimate of PTSD among ADSMs with mTBI at 36% (95% CI, 30%-41%, P < .01, I2 = 96%). Cohort studies indicated a slightly higher prevalence of 38% (95% CI, 19%-59%, P < .01, I2 = 98%), whereas cross-sectional studies provided a marginally lower prevalence of 34% (95% CI, 27%-40%, P < .01, I2 = 92%). CONCLUSION: Methodological differences, including diagnostic criteria variability, contribute to the observed variability in prevalence estimates. Despite methodological challenges, this study provides crucial insights into the pooled prevalence of comorbid PTSD and mTBI within the military, emphasizing the need for standardized methodologies and further research to refine understanding and support strategies for affected individuals.

The relationship between fatigue, pruritus, and thirst distress with quality of life among patients receiving hemodialysis: a mediator model to test concept of treatment adherence.

Hemodialysis is a conservative treatment for end-stage renal disease. It has various complications which negatively affect quality of life (QOL). This study aimed to examine the relationship between fatigue, pruritus, and thirst distress (TD) with QOL of patients receiving hemodialysis, while also considering the mediating role of treatment adherence (TA). This cross-sectional study was carried out in 2023 on 411 patients receiving hemodialysis. Participants were consecutively recruited from several dialysis centers in Iran. Data were collected using a demographic information form, the Fatigue Assessment Scale, the Thirst Distress Scale, the Pruritus Severity Scale, the 12-Item Short Form Health Survey, and the modified version of the Greek Simplified Medication Adherence Questionnaire for Hemodialysis Patients. Covariance-based structural equation modeling was used for data analysis. The structural model and hypothesis testing results showed that all hypotheses were supported in this study. QOL had a significant inverse association with fatigue, pruritus, and TD and a significant positive association with TA. TA partially mediated the association of QOL with fatigue, pruritus, and TD, denoting that it helped counteract the negative association of these complications on QOL. This model explained 68.5% of the total variance of QOL. Fatigue, pruritus, and TD have a negative association with QOL among patients receiving hemodialysis, while TA reduces these negative associations. Therefore, TA is greatly important to manage the associations of these complications and improve patient outcomes. Healthcare providers need to assign high priority to TA improvement among these patients to reduce their fatigue, pruritus, and TD and improve their QOL. Further studies are necessary to determine the most effective strategies for improving TA and reducing the burden of complications in this patient population.

Farsi Version of the Body Image Concern Inventory in Iranian Hemodialysis Patients: Validity and Reliability.

Background and Purpose: Patients on hemodialysis often struggle with their body image. This study was conducted with the aim of investigating the validity and reliability of the Persian version of the body image concern questionnaire for the first time in hemodialysis patients in Iran. Methods: In this cross-sectional study, 400 hemodialysis patients from Iran were assessed using the Body Image Concern Inventory (BICI). By using exploratory factor analysis (EFA; with Maximum Likelihood Factor Analysis and Promax Rotation) and confirmatory factor analysis, the construct validity of BICI was assessed. To check for internal consistency, the average interitem correlation, Cronbach's alpha, and McDonald's omega coefficients were used. Stability was assessed with intraclass correlation coefficient (ICC). Results: The participants' average age was 53.2 (SD = 13.2) years, and more than half of them were women (54.60%). Four factors extracted from exploratory factor analysis (EFA) show that the total cumulative variance explained by these factors was 44.46% of the total variance. Item factor loadings varied between 0.415 and 0.970. Internal consistency coefficients were considered acceptable (>0.7). Also, stability was evaluated as good (ICC = .839). Conclusions: The Farsi version of the BICI scale as a self-report measure of concerns about dysmorphic appearance has 19 items and shows acceptable reliability and validity. Consequently, the scale can be used by nurses to evaluate body image among Farsi-speaking hemodialysis patients, which can help them to take necessary actions to decrease the level of concerns in these patients.

Being part of something: transformative outcomes of a community-based participatory study.

OBJECTIVES: Calls for public health practices, including research, to better integrate social theories of power, agency, and social change suggest that increased reflexivity about both the process and outcomes of community engagement is warranted. Yet few community-based participatory research (CBPR) projects specifically report nonresearch outcomes of such projects. The authors analyzed "secondary outcomes" of Protecting the 'Hood Against Tobacco (PHAT), a CBPR project conducted in San Francisco, California. METHODS: Interpretive analysis of quasi-ethnographic project documentation, including meeting minutes, field notes, retrospective observations, and interviews. RESULTS: PHAT participation created "ripple effects," encouraging healthier behaviors and public health promotion among community research partners, prompting academics to confront power asymmetries and recognize community knowledge, and widening social networks. CONCLUSIONS: CBPR benefits both communities and researchers beyond the findings of the research itself. More systematically capturing these effects, perhaps through wider use of ethnographic approaches, could help enhance understanding of CBPR's true contributions.

A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults with Type 2 Diabetes Mellitus: A SPIRIT Compliant Study Protocol for Randomized Controlled Trial.

Background: The rising burden of type 2 diabetes mellitus (DM) and its associated complications is affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care systems and the national economies. Given the enormous health and economic impact, preventing type 2 DM progression and reducing the risk of complications require immediate attention. Evidence from western countries suggests that self-management can slow the progression of type 2 DM and minimize the risk of major complications lowering health-care costs. Effective self-management, however, demands patients' confidence and their full commitment to perform self-care tasks necessitating a patient-centered approach. This study aims to test the efficacy of a patient-centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM. Patients and Methods: The study will be carried out as a parallel arm, randomized, controlled trial in four public tertiary care hospitals in Faisalabad, Pakistan. A total of 612 patients with type 2 DM will be recruited and randomly assigned to two groups: a control and an intervention group. The intervention group will receive a patient-centered self-management intervention for eight weeks duration. Subjects will be followed up for three months. The primary outcome will be glycemic control (HbA1c), and secondary outcome variables will include self-efficacy and self-care behaviors all measured at three points in time (baseline, at the end of intervention and at three months follow-up). Discussion: This randomized controlled trial will provide critical information about the efficacy of patient-centered self-management intervention in improving HbA1c, self-efficacy and self-care behaviors. If successful, this evidence-based care intervention may be provided to all DM patients by updating hospital policies. Trial Registration: NIH: US National Library of Medicine clinicaltrials.gov Identifier: NCT05491252, Shifa Tameer e Millat University Protocol Record: 335-21. Registration date: August 08, 2022. Recruitment began: April 21, 2022. Recruitment completed: July 27, 2022. URL http://www.clinicaltrials.gov.