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  • 1.
    Barbabella, Francesco
    et al.
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. National Institute of Health and Science on Ageing (INRCA), Italy.
    Poli, Arianna
    National Institute of Health and Science on Ageing (INRCA), Italy ; Linköping University.
    Andréasson, Frida
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. Swedish Family Care Competence Centre (NKA), Sweden.
    Salzmann, Benjamin
    National Institute of Health and Science on Ageing (INRCA), Italy ; wir pflegen e.V., Germany.
    Papa, Roberta
    National Institute of Health and Science on Ageing (INRCA), Italy.
    Hanson, Elizabeth
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. Swedish Family Care Competence Centre (NKA), Sweden ; Eurocarers, Belgium.
    Efthymiou, Areti
    Eurocarers, Belgium ; Cyprus University of Technology, Cyprus.
    Döhner, Hanneli
    wir pflegen e.V., Germany ; Eurocarers, Belgium.
    Lancioni, Christina
    National Institute of Health and Science on Ageing (INRCA), Italy.
    Civerchia, Patrizia
    National Institute of Health and Science on Ageing (INRCA), Italy.
    Lamura, Giovani
    National Institute of Health and Science on Ageing (INRCA), Italy.
    A web-based psychosocial intervention for family caregivers of older people: results from a mixed-methods study in three European countries2016In: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 5, no 4, p. 1-16, article id e196Article in journal (Refereed)
    Abstract [en]

    Background: Informal caregiving is the main source of care for older people in Europe. An enormous amount of responsibility and care activity is on the shoulders of family caregivers, who might experience problems in their psychological well-being and in reconciling caregiving and their personal sphere. In order to alleviate such burden, there is increasing interest and growing research in Europe on Web-based support addressing family caregivers and their needs. However, the level of development and penetration of innovative Web-based services for caregivers is still quite low and the access to traditional face-to-face services can be problematic for logistic, availability, and quality reasons.

    Objective: As part of the European project INNOVAGE, a pilot study was conducted for developing and testing a Web-based psychosocial intervention aimed at empowering family caregivers of older people in Italy, Sweden, and Germany. The program offered information resources and interactive services to enable both professional and peer support.

    Methods: A mixed-methods, sequential explanatory design was adopted. Caregivers’ psychological well-being, perceived negative and positive aspects of caregiving, and social support received were assessed before and after the 3-month intervention. Poststudy, a subsample of users participated in focus groups to assist in the interpretation of the quantitative results.

    Results: A total of 94 out of 118 family caregivers (79.7%) from the three countries used the Web platform at least once. The information resources were used to different extents in each country, with Italian users having the lowest median number of visits (5, interquartile range [IQR] 2-8), whereas German users had the highest number (17, IQR 7-66) (P<.001). The interactive services most frequently accessed (more than 12 times) in all countries were the social network (29/73, 40%) and private messages (27/73, 37%). The pretest-posttest analysis revealed some changes, particularly the slight worsening of perceived positive values of caregiving (Carers of Older People in Europe [COPE] positive value subscale: P=.02) and social support received (COPE quality-of-support subscale: P=.02; Multidimensional Scale of Perceived Social Support subscale: P=.04), in all cases with small effect size (r range -.15 to -.18). Focus groups were conducted with 20 family caregivers and the content analysis of discussions identified five main themes: online social support, role awareness, caregiving activities, psychological well-being, and technical concerns. The analysis suggested the intervention was useful and appropriate, also stimulating a better self-efficacy and reappraisal of the caregivers’ role.

    Conclusions: The intervention seemed to contribute to the improvement of family caregivers’ awareness, efficacy, and empowerment, which in turn may lead to a better self-recognition of their own needs and improved efforts for developing and accessing coping resources. A major implication of the study was the finalization and implementation of the InformCare Web platform in 27 European countries, now publicly accessible (www.eurocarers.org/informcare).

  • 2.
    Bonn, Stephanie E
    et al.
    Karolinska Institutet.
    Bergman, Patrick
    Linnaeus University, Faculty of Social Sciences, Department of Sport Science.
    Trolle-Lagerros, Ylva
    Karolinska Institutet;Karolinska University Hospital Huddinge.
    Sjölander, Arvid
    Karolinska Institutet.
    Bälter, Katarina
    Karolinska Institutet.
    A validation study of the web-based physical activity questionnaire Active-Q against the GENEA Accelerometer2015In: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 4, no 3, article id e86Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Valid physical activity assessment in epidemiological studies is essential to study associations with various health outcomes.

    OBJECTIVE:

    To validate the Web-based physical activity questionnaire Active-Q by comparing results of time spent at different physical activity levels with results from the GENEA accelerometer and to assess the reproducibility of Active-Q by comparing two admissions of the questionnaire.

    METHODS:

    A total of 148 men (aged 33 to 86 years) responded to Active-Q twice and wore the accelerometer during seven consecutive days on two occasions. Time spent on six different physical activity levels including sedentary, light (LPA), moderate (MPA), and vigorous (VPA) as well as additional combined categories of sedentary-to-light and moderate-to-vigorous (MVPA) physical activity was assessed. Validity of Active-Q was determined using Spearman correlation coefficients with 95% confidence intervals (CI) and the Bland-Altman method. Reproducibility was assessed using intraclass correlation coefficients (ICCs) comparing two admissions of the questionnaire.

    RESULTS:

    The validity correlation coefficients were statistically significant for time spent at all activity levels; sedentary (r=0.19, 95% CI: 0.04-0.34), LPA (r=0.15, 95% CI: 0.00-0.31), sedentary-to-light (r=0.35, 95% CI: 0.19-0.51), MPA (r=0.27, 95% CI: 0.12-0.42), VPA (r=0.54, 95% CI: 0.42-0.67), and MVPA (r=0.35, 95% CI: 0.21-0.48). The Bland-Altman plots showed a negative mean difference for time in LPA and positive mean differences for time spent in MPA, VPA and MVPA. The ICCs of test-retest reliability ranged between r=0.51-0.80 for the different activity levels in Active-Q.

    CONCLUSIONS:

    More moderate and vigorous activities and less light activities were reported in Active-Q compared to accelerometer measurements. Active-Q shows comparable validity and reproducibility to other physical activity questionnaires used today.

  • 3.
    Ekstedt, Mirjam
    et al.
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. Karolinska Institutet, Sweden.
    Schildmeijer, Kristina
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences.
    Wennerberg, Carolina
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. Kalmar County Council, Sweden.
    Nilsson, Lina
    Linnaeus University, Faculty of Technology, Department of Informatics. Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry.
    Wannheden, Carolina
    Karolinska Institutet, Sweden.
    Hellström, Amanda
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences.
    Enhanced patient activation in cancer care transitions: protocol for a randomized controlled trial of a tailored eectronic health intervention for men with prostate cancer2019In: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 8, no 3, p. 1-13, article id e11625Article in journal (Refereed)
    Abstract [en]

    Background: Prostate cancer has increased in incidence worldwide and is the leading cause of cancer death in 24 countries. The most common treatment is radical prostatectomy. However, surgery is associated with postoperative complications such as urinary incontinence and sexual dysfunction, causing decreased quality of life. If survivors are encouraged to be more active in self-care management, the symptom burden may decrease and quality of life may improve. An electronic health (eHealth) intervention based on motivational behavioral theory has been developed for this purpose.

    Objective: This study aimed to compare the effectiveness of standard care in combination with a tailored eHealth and mobile health self-management support system, electronic Patient Activation in Treatment at Home (ePATH), with standard care of adverse effects of prostate cancer treatment (urinary incontinence and sexual functioning) in men undergoing radical prostatectomy. The secondary aim was to test the effect on patient activation, motivation, overall well-being, and health literacy over time in and between groups.

    Methods: A pragmatic multicenter, block-randomized controlled trial with 2 study arms, standard care (control) and eHealth-assisted standard care (intervention), for patients undergoing radical prostatectomy. For 80% power, a sample of 242 men will need to be recruited.

    Results: Recruitment started in January 2018 and is expected to be completed by August 2019. Data collection will be completed in August 2020. The first cross-sectional results from this trial are anticipated to be published in January 2020.

    Conclusions: With the increasing number of prostate cancer survivors, attention should be paid to rehabilitation, psychosocial care, and support for endurance of self-care to reduce suffering from adverse treatment effects, poor quality of life, and depression because of postoperative complications. This project may increase knowledge of how patients can be supported to feel involved in their care and returning to as normal a life as possible. The anticipated effects of ePATH could improve health outcomes for individuals and facilitate follow-up for health care professionals.

  • 4.
    Johansson Östbring, Malin
    et al.
    Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry. Kalmar County Council.
    Eriksson, Tommy
    Malmö University;Norwegian University of Sciences and Technology, Norway.
    Petersson, Göran
    Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry.
    Hellström, Lina
    Kalmar County Council.
    Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation2018In: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 7, no 1, p. 1-12, article id e21Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation.

    OBJECTIVE: This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective.

    METHODS: The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease.

    RESULTS: The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known.

    CONCLUSIONS: This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions.

  • 5.
    Johansson Östbring, Malin
    et al.
    Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry. Kalmar County Council.
    Eriksson, Tommy
    Malmö University;Norweigan University of Sciences and Technology, Norway.
    Petersson, Göran
    Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry.
    Hellström, Lina
    Kalmar County Council.
    Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life2018In: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 7, no 2, p. 1-15, article id e57Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Preventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients' adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes.

    OBJECTIVE: This study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately.

    METHODS: The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient's medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use.

    RESULTS: The protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019.

    CONCLUSIONS: The MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy).

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