The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c ≥64 mmol/mol: a group-based randomised controlled trial.

OBJECTIVES: To determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA1c and type 1 diabetes mellitus (DM) was superior to 'care as usual' in improving HbA1c and psychological functioning. SETTING: An outpatient clinic at a university hospital in Western Norway. PARTICIPANTS: A total of 178 adults (all Caucasian) aged 18-55 (mean age 36.7±10.7, 62% women) with type 1 DM for at least 1 year and HbA1c ≥64 mmol/mol (8.0%) were randomly assigned to participate in either GSD-GT or a control group (CG). Exclusion criteria were severe comorbidity, major psychiatric disorder, cognitive deficiency/language barriers and pregnancy. INTERVENTION: Intervention group met seven times for 2 hours over 14 weeks to promote patient autonomy and intrinsic motivation using reflection sheets and advanced professional communication in accordance with the GSD methodology. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was HbA1c and secondary outcomes (all outcomes 9 months post intervention) were self-monitored blood glucose frequency, self-reported diabetes competence, autonomy support by healthcare providers (Health Care Climate Questionnaire), autonomous versus controlled diabetes motivation (Treatment Self-Regulation Questionnaire), diabetes distress (Problem Areas In Diabetes Scale (PAID) and Diabetes Distress Scale (DDS)), self-esteem (Rosenberg Self-Esteem Scale) and psychological well-being (World Health Organization five-item Well-Being Index scale). RESULTS: Among participants allocated to the GSD-GT (=90) 48 completed the study, whereas 83 completed in the CG (n=88). With 95% CIs GSD-GT did not have effect on HbA1c (B -0.18, CI (-0.48, 0.12), p=0.234). GSD-GT improved autonomy-motivated behaviour (B 0.51, CI (0.25, 0.77), p<0.001), diabetes distress (PAID, B -6.96, CI (-11.40, -2.52), p=0.002), total DDS (B -5.15, CI (-9.34, -0.96), p=0.016), DDS emotional burden (B -7.19, CI (-13.20, -1.19), p=0.019) and self-esteem (B 1.43, CI (0.34, 2.52), p=0.011). CONCLUSIONS: Results from this behavioural intervention must be interpreted cautiously because of recruitment and attrition problems. Medical outcomes did not improve. Psychological outcomes improved, especially reduced diabetes distress. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT 01317459.

Severity and duration of diabetic foot ulcer (DFU) before seeking care as predictors of healing time: A retrospective cohort study.

OBJECTIVES: To investigate whether A) duration of ulcer before start of treatment in specialist health care, and B) severity of ulcer according to University of Texas classification system (UT) at start of treatment (baseline), are independent predictors of healing time. METHODS: This retrospective cohort study, based on electronic medical record data, included 105 patients from two outpatient clinics in Western Norway with a new diabetic foot ulcer during 2009-2011. The associations of duration of ulcer and ulcer severity with healing time were assessed using cumulative incidence curves and subdistribution hazard ratio estimated using competing risk regression with adjustment for potential confounders. RESULTS: Of the 105 participants, 45.7% achieved ulcer healing, 36.2% underwent amputations, 9.5% died before ulcer healing and 8.5% were lost to follow-up. Patients who were referred to specialist health care by a general practitioner ≥ 52 days after ulcer onset had a 58% (SHR 0.42, CI 0.18-0.98) decreased healing rate compared to patients who were referred earlier, in the adjusted model. High severity (grade 2/3, stage C/D) according to the UT classification system was associated with a decreased healing rate compared to low severity (grade1, stage A/B or grade 2, stage A) with SHR (95% CI) equal to 0.14 (0.05-0.43) after adjustment for referral time and other potential confounders. CONCLUSION: Early detection and referral by both the patient and general practitioner are crucial for optimal foot ulcer healing. Ulcer grade and severity are also important predictors for healing time, and early screening to assess the severity and initiation of prompt treatment is important.

The relationships among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being in Norwegian adults with Type 1 diabetes.

AIMS: To examine the associations among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being, and determine whether diabetes-related quality of life is a mediator of the relationship between fear of hypoglycaemia and psychological well-being in adults with Type 1 diabetes. METHODS: A total of 235 of 319 invited adults (18-69years) with Type 1 diabetes agreed to participate. Hierarchical linear regression was applied to 188 individuals with complete data. Mediation analysis was used to determine whether diabetes-related quality of life mediated the relationship between fear of hypoglycaemia and psychological well-being. RESULTS: Fear of hypoglycaemia was significantly associated with diabetes-related quality of life and psychological well-being. The behaviour and worry components of fear of hypoglycaemia were significantly associated with diabetes-related quality of life (behaviour component: unstandardised coefficient=-0.04, p<0.001, standardised coefficient=-0.40; worry component: unstandardised coefficient=-0.01, p=0.041, standardised coefficient=-0.18). Fear of hypoglycaemia worry had a significant independent association with psychological well-being (unstandardised coefficient=-0.28, p=0.009, standardised coefficient=-0.25), whereas fear of hypoglycaemia behaviour did not. Diabetes-related quality of life mediated approximately half of the association between fear of hypoglycaemia worry and psychological well-being. CONCLUSIONS: Hypoglycaemic episodes can have serious consequences, and assessing fear of hypoglycaemia might help health care providers offer suitable care strategies to individuals with Type 1 diabetes.

Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol.

INTRODUCTION: Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c). METHODS AND ANALYSIS: A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention. ETHICS AND DISSEMINATION: The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print, and presented at research conferences. TRIAL REGISTRATION NUMBER: NCT02575599.

Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo).

BACKGROUND: This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. OBJECTIVE: To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. METHODS: The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of foot ulcers. In addition, qualitative substudies are being performed to provide a more comprehensive evaluation of the ongoing processes during the trial with the patients in the intervention and control groups and those health care professionals either working in primary care or in specialist care delivering the intervention. RESULTS: The project has been funded. The inclusion of patients started in September 2012. Because recruitment goals were not met in the initial period, two more clinical sites have been included to meet sample size requirements. Patient recruitment will continue until June 2016. Data collection in the qualitative substudies has been completed. CONCLUSIONS: This telemedicine trial operates in a novel setting and targets patients with diabetes-related foot ulcers during a 12-month follow-up period. The trial addresses whether integrated care using telemedicine between primary and specialist health care can be an equivalent alternative to standard outpatient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/show/NCT01710774 (Archived by WebCite at http://www.webcitation.org/6im6KfFov).

Outcomes of Unicompartmental Knee Arthroplasty After Aseptic Revision to Total Knee Arthroplasty: A Comparative Study of 768 TKAs and 578 UKAs Revised to TKAs from the Norwegian Arthroplasty Register (1994 to 2011).

BACKGROUND: The general recommendation for a failed primary unicompartmental knee arthroplasty (UKA) is revision to a total knee arthroplasty (TKA). The purpose of the present study was to compare the outcomes, intraoperative data, and mode of failure of primary UKAs and primary TKAs revised to TKAs. METHODS: The study was based on 768 failed primary TKAs revised to TKAs (TKA→TKA) and 578 failed primary UKAs revised to TKAs (UKA→TKA) reported to the Norwegian Arthroplasty Register between 1994 and 2011. Patient-reported outcome measures (PROMs) including the EuroQol EQ-5D, the Knee Injury and Osteoarthritis Outcome Score (KOOS), and visual analog scales assessing satisfaction and pain were used. We performed Kaplan-Meier and Cox regression analyses adjusting for propensity score to assess the survival rate and the risk of re-revision and multiple linear regression analyses to estimate the differences between the two groups in mean PROM scores. RESULTS: Overall, 12% in the UKA→TKA group and 13% in the TKA→TKA group underwent re-revision between 1994 and 2011. The ten-year survival percentage of UKA→TKA versus TKA→TKA was 82% versus 81%, respectively (p = 0.63). There was no difference in the overall risk of re-revision for UKA→TKA versus TKA→TKA (relative risk [RR] = 1.2; p = 0.19), or in the PROM scores. However, the risk of re-revision was two times higher for TKA→TKA patients who were greater than seventy years of age at the time of revision (RR = 2.1; p = 0.05). A loose tibial component (28% versus 17%), pain alone (22% versus 12%), instability (19% versus 19%), and deep infection (16% versus 31%) were major causes of re-revision for UKA→TKA versus TKA→TKA, respectively, but the observed differences were not significant, with the exception of deep infection, which was significantly greater in the TKA→TKA group (RR = 2.2; p = 0.03). The surgical procedure of TKA→TKA took a longer time (mean of 150 versus 114 minutes) and more of the procedures required stems (58% versus 19%) and stabilization (27% versus 9%) compared with UKA→TKA. CONCLUSIONS: Despite TKA→TKA seeming to be a technically more difficult surgical procedure, with a higher percentage of re-revisions due to deep infection compared with UKA→TKA, the overall outcomes of UKA→TKA and TKA→TKA were similar.

Secondary patella resurfacing in painful non-resurfaced total knee arthroplasties : A study of survival and clinical outcome from the Norwegian Arthroplasty Register (1994-2011).

PURPOSE: In Norway, 19 % of revisions of non-resurfaced total knee arthroplasties done for knee pain between 1994 and 2011 were Secondary Patella Resurfacing (SPR). It is, however, unclear whether SPR actually resolves the pain. The aim was to investigate prostheses survival and clinical outcomes following SPR. METHOD: A total of 308 knees (301 patients) with SPR were used to assess implant survival, and a sub-cohort (n = 114 out of 301 patients) with Patient Reported Outcome Measures (PROMs) data were used to assess the clinical outcomes. The EuroQol (EQ-5D), the Knee Injury and Osteoarthritis Outcome Score, and Visual Analogue Scales on satisfaction and pain were used to collect PROM data. Outcomes were analysed by Kaplan-Meier, Cox regression, and multiple linear regression. RESULTS: The five- and ten-year Kaplan-Meier survival percentages were 91 % and 87 %, respectively. Overall, 35 knees were re-revised at a median follow-up of eight years and pain alone (10 knees) was the main cause of re-revision. Younger patients (<60 years) had nearly nine times higher risk of re-revision compared to older patients (>70 years) (RR = 8.6; p < 0.001). Mean EQ-5D index score had improved from 0.41 (SD 0.21) preoperative to 0.56 (SD 0.25) postoperative following SPR. A total of 63 % of patients with PROM data were satisfied with the outcomes of SPR. CONCLUSION: The long-term prostheses survival following SPR was satisfactory, although not as good as for primary knee replacement. Patients' health related quality of life improved significantly following SPR. Still, more than a third of patients with PROMs data were dissatisfied with the outcomes of the SPR procedure.

Involving people with diabetes and the wider community in diabetes research: a realist review protocol.

BACKGROUND: Patient and public involvement in diabetes research is now actively encouraged in different countries because it is believed that involving people with experience of the condition will improve the quality and relevance of the research. However, reviews of patient involvement have noted that inadequate resources, patients' and communities' lack of research knowledge, and researchers' lack of skills to involve patients and communities in research may present significant contextual barriers. Little is known about the extent of patient/community involvement in designing or delivering interventions for people with diabetes. A realist review of involvement will contribute to assessing when, how and why involvement works, or does not work, to produce better diabetes interventions. METHODS/DESIGN: This protocol outlines the process for conducting a realist review to map how patients and the public have been involved in diabetes research to date. The review questions ask the following: How have people with diabetes and the wider community been involved in diabetes research? What are the characteristics of the process that appear to explain the relative success or failure of involvement? How has involvement (or lack of involvement) in diabetes research influenced the development and conduct of diabetes research? The degree of support in the surrounding context will be assessed alongside the ways in which people interact in different settings to identify patterns of interaction between context, mechanisms and outcomes in different research projects. The level and extent of the involvement will be described for each stage of the research project. The descriptions will be critically reviewed by the people with diabetes on our review team. In addition, researchers and patients in diabetes research will be asked to comment. Information from researcher-patient experiences and documents will be compared to theories of involvement across a range of disciplines to create a mid-range theory describing how involvement (or lack of involvement) in diabetes research influences the development and conduct of diabetes research.

Assessing fear of hypoglycemia in a population-based study among parents of children with type 1 diabetes - psychometric properties of the hypoglycemia fear survey - parent version.

BACKGROUND: In the treatment of childhood type 1 diabetes, being aware of the parents' fear of hypoglycemia is important, since the parents' fear may influence the management of treatment and the children's blood glucose regulation. The availability of proper instruments to assess the parents' fear of hypoglycemia is essential. Thus, the aim of this study was to examine the psychometric properties of the Hypoglycemia Fear Survey - Parent version (HFS-P). METHODS: In a Norwegian population-based sample, 176 parents representing 102 children with type 1 diabetes (6-15 years old) completed the HFS-P, comprising a 15-item worry subscale and a 10-item behavior subscale. We performed exploratory and confirmatory factor analysis and further analysis of the scales' construct validity, content validity and reliability. RESULTS: The Norwegian version of the HFS-P had an acceptable factor structure and internal consistency for the worry subscale, whereas the structure and internal consistency of the behavior subscale was more questionable. The HFS-P subscales were significantly correlated (from moderately to weakly) with symptoms of emotional distress, as measured by the Hopkins Symptom Checklist - 25 items. The mothers scored higher than fathers on both HFS-P subscales, but the difference was not statistically significant for the worry subscale. CONCLUSIONS: The HFS-P worry subscale seems to be a valid scale for measuring anxiety-provoking aspects of hypoglycemia, and the validity of the HFS-P behavior subscale needs to be investigated further.

Is depression a risk factor for diabetic foot ulcers? 11-years follow-up of the Nord-Trøndelag Health Study (HUNT).

AIM: To prospectively examine whether depressive symptoms increase the risk of diabetes and a diabetic foot ulcer. METHODS: The Nord-Trøndelag Health Study (HUNT) is a community-based longitudinal study. The Hospital Anxiety and Depression Scale (HADS-D subscale) assessed depressive symptoms. We followed individuals with complete HADS-D data from HUNT2 (1995-97) and assessed whether they reported diabetes with or without a history of diabetic foot ulcer (DFU) in HUNT3 (2006-08) (n=36,031). Logistic regression was used to investigate the effect of depressive symptoms on subsequent development of diabetes and of DFU. RESULTS: Unadjusted odds for reporting diabetes at follow-up was higher among individuals who reported a HADS-D score≥8 at baseline (OR 1.30 95% CI, 1.07-1.57) than among those reporting a lower score. After adjusting for age, gender and BMI, this association was no longer significant. The odds of developing a DFU was almost two-fold (OR=1.95 95% CI, 1.02-3.74) for those reporting a HADS-D score of 8-10, and 3-fold (OR=3.06 95% CI, 1.24-7.54) for HADS-D scores≥11, compared to HADS-D scores<8, after adjusting for age, gender and serum glucose. CONCLUSIONS: Symptoms of depression at baseline are associated with an increased risk of a diabetic foot ulcer in a dose response manner during this 11-year follow-up.

Relationships of diabetes-specific emotional distress, depression, anxiety, and overall well-being with HbA1c in adult persons with type 1 diabetes.

OBJECTIVE: Emotional problems are common in adults with diabetes, and knowledge about how different indicators of emotional problems are related with glycemic control is required. The aim was to examine the relationships of diabetes-specific emotional distress, depression, anxiety, and overall well-being with glycosylated hemoglobin (HbA1c). METHODS: Of the 319 adults with type 1 diabetes attending the endocrinology outpatient clinic at a university hospital in Norway, 235 (74%) completed the Diabetes Distress Scale, the Problem Areas in Diabetes Survey, the Hospital Anxiety and Depression Scale, and the World Health Organization-Five Well-Being Index. Blood samples were taken at the time of data collection to determine HbA1c. Regression analyses examined associations of diabetes-specific emotional distress, anxiety, depression, and overall well-being with HbA1c. The relationship between diabetes-specific emotional distress and HbA1c was tested for nonlinearity. RESULTS: Diabetes-specific emotional distress was related to glycemic control (DDS total: unstandardized coefficient=0.038, P<.001; PAID total: coefficient=0.021, P=.007), but depression, anxiety, and overall well-being were not. On the DDS, only regimen-related distress was independently related to HbA1c (coefficient=0.056, P<.001). A difference of 0.5 standard deviation of baseline regimen distress is associated with a difference of 0.6 in HbA1c. No significant nonlinearity was detected in the relationship between diabetes-specific distress and HbA1c. CONCLUSIONS: To stimulate adequate care strategies, health personnel should acknowledge depression and diabetes-specific emotional distress as different conditions in clinical consultations. Addressing diabetes-specific emotional distress, in particular regimen distress, in clinical consultation might improve glycemic control.

Challenges in managing elderly people with diabetes in primary care settings in Norway.

OBJECTIVE: To explore the experiences and clinical challenges that nurses and nursing assistants face when providing high-quality diabetes-specific management and care for elderly people with diabetes in primary care settings. DESIGN: Focus-group interviews. SUBJECTS AND SETTING: Sixteen health care professionals: 12 registered nurses and four nursing assistants from nursing homes (10), district nursing service (5), and a service unit (1) were recruited by municipal managers who had local knowledge and knew the workforce. All the participants were women aged 32-59 years with clinical experience ranging from 1.5 to 38 years. RESULTS: Content analysis revealed a discrepancy between the level of expertise which the participants described as important to delivering high-quality care and their capacity to deliver such care. The discrepancy was due to lack of availability and access to current information, limited ongoing support, lack of cohesion among health care professionals, and limited confidence and autonomy. Challenges to delivering high-quality care included complex, difficult patient situations and lack of confidence to make decisions founded on evidence-based guidelines. CONCLUSION: Participants lacked confidence and autonomy to manage elderly people with diabetes in municipal care settings. Lack of information, support, and professional cohesion made the role challenging.

Psychometric properties of the Norwegian version of the Audit of Diabetes-Dependent Quality of Life.

PURPOSE: To examine the psychometric properties of the Norwegian version of the Audit of Diabetes-Dependent Quality of Life version 18 (ADDQoL-18). METHODS: We assessed the reliability (Cronbach's alpha and intraclass correlations) and construct validity (confirmatory factor analysis and Pearson's correlation coefficients) of the instrument in a sample of 292 adults in Norway aged 42.3 (SD 14.2) years. RESULTS: Internal consistency (Cronbach's alpha 0.88) and 4-week test-retest stability (intraclass correlations = 0.87) were satisfactory. Confirmatory factor analysis indicated that the one-factor structure of the ADDQoL-18 fits moderately (χ (2)/df ratio = 3.846, comparative fit index = 0.792, root mean square error of approximation = 0.099). Standardized coefficients showed that all domains loaded >0.4, except for one item. We found a satisfactory correlation between the ADDQoL-18 and the SF-36 Health Survey summary scales (physical health and mental health summary scales) and the Hospital Anxiety and Depression Scale. The total score was negatively associated with HbA1c (r = -0.18; P < 0.002), indicating that lower scores on the ADDQoL-18 were related to poorer glycemic control. Analysis regarding discriminant validity showed that the average weighted impact scores were mostly reduced among those reporting neuropathy and foot problems. CONCLUSIONS: The Norwegian version of the ADDQoL-18 showed high internal consistency, good test-retest reliability, and similar construct validity as the original instrument. Overall, the results supported the ADDQoL-18 being feasible for use in Norway.

Comparison of health-related quality of life between patients with chronic obstructive pulmonary disease and the general population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is associated with lower health-related quality of life (HRQOL). Previous research has focused primarily on HRQOL in these patients, whereas few studies have compared HRQOL between patients with COPD and the general population. AIM: The aim of this study was to evaluate differences in HRQOL between patients with COPD stage 2 to COPD stage 4 waiting to begin an outpatient pulmonary rehabilitation (PR) programme and Norwegian individuals with and without other chronic conditions. METHODS: A comparative survey design was used in this study of 100 patients with COPD waiting to begin PR and 3594 individuals from the general population. The SF-36 questionnaire was used to evaluate HRQOL. RESULTS: Compared with the healthy general population, COPD patients waiting to begin PR had lower scores on all SF-36 components and on the physical and mental health summary components (p < 0.001). Scores for physical function, physical role, general health, vitality, social function, emotional role and the physical health component differed markedly between patients and the general population. Patients with COPD stage 4 had lower HRQOL than did the general population and those with COPD stage 2 and COPD stage 3. CONCLUSIONS: The burden of COPD significantly affects HRQOL in patients with COPD waiting to begin PR, and those with COPD stage 4 are most affected. Action should be taken to support especially those patients with COPD stage 4.

Anxiety and depression following pulmonary rehabilitation.

AIM: The aim of this study was to evaluate changes and predictive factors of anxiety and depression in patients with chronic obstructive pulmonary disease (COPD) before and up to 3 months after pulmonary rehabilitation (PR). METHODS: A single group longitudinal design of patients with COPD underwent a PR programme. The measurements took place at baseline (T1: N=100), immediately before (T2: N=66), immediately after (T3: N=54) and 3 months after (T4: N=43) the programme. The programme was a 6-week outpatient programme, including education, psychosocial support and training sessions. Anxiety and depression were measured by the Hospital Anxiety and Depression Scale, self-efficacy by the COPD self-efficacy scale, lung function by spirometry and exercise capacity by incremental shuttle walking test. Mixed effect model analyses were used. RESULTS: Results showed a tendency of less anxiety and depression immediately after (T3) compared with immediately before (T2) the PR programme, but the changes were not significant. Results also showed that female reported significantly more anxiety than male (p=0.019), better exercise capacity predicted significantly less depression (p=0.049), and higher self-efficacy predicted both significantly less anxiety (p=0.001) and less depression (p=0.005). CONCLUSIONS: A tendency of less anxiety and depression during the PR programme was found, but the changes were not significant. Higher level of self-efficacy and better exercise capacity are suggested to relieve anxiety and depression.

Diabetes-related emotional distress in adults: reliability and validity of the Norwegian versions of the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS).

BACKGROUND: Regular assessment of diabetes-related emotional distress is recommended to identify high-risk people with diabetes and to further prevent negative effects on self-management. Nevertheless, psychological problems are greatly under diagnosed. Translating and testing instruments for psychosocial assessment across languages, countries and cultures allow for further research collaboration and enhance the prospect of improving treatment and care. OBJECTIVES: To examine the psychometric properties of the Norwegian versions of the Problem Areas in Diabetes Scale and the Diabetes Distress Scale. DESIGN: Cross-sectional survey design. SETTINGS: A sample comprising adults with diabetes (response rate 71%) completed the Problem Areas in Diabetes Scale and the Diabetes Distress Scale, which were translated into Norwegian with standard forward-backwards translation. PARTICIPANTS: The study included 292 participants with type 1 (80%) and type 2 diabetes (20%) aged 18-69 years, 58% males, mean diabetes duration 17.3 years (11.6), mean HbA(1c) 8.2% (1.6). METHODS: We used exploratory factor analysis with principal axis factoring and varimax rotation to investigate the factor structure and performed confirmatory factor analysis to test the best fit of a priori-defined models. Convergent and discriminate validity were examined using the Short Form-36 Health Survey, Hospital Anxiety and Depression Scale and demographic and disease-related clinical variables. We explored reliability by internal consistency and test-retest analysis. RESULTS: Exploratory factor analysis supported a four-factor model for the Diabetes Distress Scale. Confirmatory factor analysis indicated that the data and the hypothesized model for the Diabetes Distress Scale fit acceptably but not for the Problem Areas in Diabetes Scale. Greater distress assessed with both instruments correlated moderately with lower health-related quality of life and greater anxiety and depression. The instruments discriminated between those having additional health conditions or disabilities, foot problems or neuropathy. Women and participants with higher HbA(1c) levels reported significantly higher diabetes-related emotional distress. CONCLUSIONS: The Norwegian versions of the Problem Areas in Diabetes Scale and the Diabetes Distress Scale have satisfactory psychometric properties and can be used to map diabetes-related emotional distress for diagnostic or clinical use. The Diabetes Distress Scale also contributes to identifying sub-domains of distress and seems promising for use in clinical trials.

Predictors of heart-focused anxiety in patients undergoing genetic investigation and counseling of long QT syndrome or hypertrophic cardiomyopathy: a one year follow-up.

Since Long QT syndrome and Hypertrophic cardiomyopathy are inherited cardiac disorders that may cause syncope, palpitations, serious arrhythmias, and sudden cardiac death, at-risk individuals may experience heart-focused anxiety. In a prospective multi-site study, 126 Norwegian patients attending genetic counseling were followed 1 year with multiple administration of questionnaires, including the Cardiac Anxiety Questionnaire, measuring three distinct symptoms of heart-focused anxiety- avoidance, attention, and fear-in mixed linear analyses. Overall, at 1-year follow-up, patients with clinical diagnosis as compared to patients at genetic risk had significantly higher scores of avoidance (p < .002), attention (p < .005), and fear (p < .007). Sudden cardiac death in close relatives, uncertainty whether other relatives previously had undergone genetic testing, patients' perceived general health, self-efficacy expectations and procedural satisfaction with genetic counseling were influential in predicting the different symptoms of heart-focused anxiety over time.

Psychosocial family factors and glycemic control among children aged 1-15 years with type 1 diabetes: a population-based survey.

BACKGROUND: Being the parents of children with diabetes is demanding. Jay Belsky's determinants of parenting model emphasizes both the personal psychological resources, the characteristics of the child and contextual sources such as parents' work, marital relations and social network support as important determinants for parenting. To better understand the factors influencing parental functioning among parents of children with type 1 diabetes, we aimed to investigate associations between the children's glycated hemoglobin (HbA1c) and 1) variables related to the parents' psychological and contextual resources, and 2) frequency of blood glucose measurement as a marker for diabetes-related parenting behavior. METHODS: Mothers (n = 103) and fathers (n = 97) of 115 children younger than 16 years old participated in a population-based survey. The questionnaire comprised the Life Orientation Test, the Oslo 3-item Social Support Scale, a single question regarding perceived social limitation because of the child's diabetes, the Relationship Satisfaction Scale and demographic and clinical variables. We investigated associations by using regression analysis. Related to the second aim hypoglycemic events, child age, diabetes duration, insulin regimen and comorbid diseases were included as covariates. RESULTS: The mean HbA1c was 8.1%, and 29% had HbA1c ≤ 7.5%. In multiple regression analysis, lower HbA1c was associated with higher education and stronger perceptions of social limitation among the mothers. A higher frequency of blood glucose measurement was significantly associated with lower HbA1c in bivariate analysis. Higher child age was significantly associated with higher HbA1c both in bivariate and multivariate analysis. A scatterplot indicated this association to be linear. CONCLUSIONS: Most families do not reach recommended treatment goals for their child with type 1 diabetes. Concerning contextual sources of stress and support, the families who successfully reached the treatment goals had mothers with higher education and experienced a higher degree of social limitations because of the child's diabetes. The continuous increasing HbA1c by age, also during the years before puberty, may indicate a need for further exploring the associations between child characteristics, context-related variables and parenting behavior such as factors facilitating the transfer of parents' responsibility and motivation for continued frequent treatment tasks to their growing children.

General anxiety, depression, and physical health in relation to symptoms of heart-focused anxiety- a cross sectional study among patients living with the risk of serious arrhythmias and sudden cardiac death.

OBJECTIVE: To investigate the role of three distinct symptoms of heart-focused anxiety (cardio-protective avoidance, heart-focused attention, and fear about heart sensations) in relation to general anxiety, depression and physical health in patients referred to specialized cardio-genetics outpatient clinics in Norway for genetic investigation and counseling. METHODS: Participants were 126 patients (mean age 45 years, 53.5% women). All patients were at higher risk than the average person for serious arrhythmias and sudden cardiac death (SCD) because of a personal or a family history of an inherited cardiac disorder (familial long QT syndrome or hypertrophic cardiomyopathy). Patients filled in, Hospital Anxiety and Depression Scale, Short-Form 36 Health Survey, and Cardiac Anxiety Questionnaire, two weeks before the scheduled counseling session. RESULTS: The patients experienced higher levels of general anxiety than expected in the general population (mean difference 1.1 (p < 0.01)). Hierarchical regression analyses showed that avoidance and fear was independently related to general anxiety, depression, and physical health beyond relevant demographic covariates (age, gender, having children) and clinical variables (clinical diagnosis, and a recent SCD in the family). In addition to heart-focused anxiety, having a clinical diagnosis was of importance for physical health, whereas a recent SCD in the family was independently related to general anxiety and depression, regardless of disease status. CONCLUSION: Avoidance and fear may be potentially modifiable symptoms. Because these distinct symptoms may have important roles in determining general anxiety, depression and physical health in at-risk individuals of inherited cardiac disorders, the present findings may have implications for the further development of genetic counseling for this patient group.

Perceived family burden and emotional distress: similarities and differences between mothers and fathers of children with type 1 diabetes in a population-based study.

BACKGROUND: Parenting children with diabetes entail an extra burden for the families. More information is needed about associations between perceived family burden and emotional distress in both mothers and fathers. OBJECTIVE: To analyze (i) perceived burden and emotional distress in mothers and fathers of children with type 1 diabetes and (ii) associations between parental burden and distress and factors related to the child. METHODS: Mothers (n = 103) and fathers (n = 97) of 115 children (1-15 yr) with type 1 diabetes participated in this population-based survey. The parents completed the Hopkins Symptom Checklist-25 items (HSCL-25), measuring emotional distress, and the Family Burden Scale, which includes five questions measuring perceived family burden related to the child's diabetes. RESULTS: Both mothers and fathers reported that the greatest burden was related to long-term health concerns. The mothers reported a significantly greater burden related to medical treatment and significantly more emotional distress than the fathers. The mothers' perceived burden was significantly correlated with emotional distress. Nighttime blood glucose measurements were significantly associated with perceived parental burden, and experienced nocturnal hypoglycemia was significantly associated with parental emotional distress. CONCLUSIONS: The higher perceived burden related to medical treatment, the more emotional distress, and the correlations between burdens and emotional distress in mothers vs. fathers emphasize the importance of discussing both parents' roles and responsibilities in relation to the child's diabetes in follow-up. In the consultations, emphasizing nighttime caregiving and nocturnal hypoglycemia might also be important to prevent emotional distress.