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      Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial

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          Abstract

          Background

          Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management programs (DMPs), for example, are run by general practitioners (GPs) for this purpose. While the importance of such measures is undeniable, there is a risk of ignoring other dimensions of care which are essential, especially for elderly patients: their spiritual needs and personal resources, loneliness and social integration, and self-care (i.e., the ability of patients to do something on their own except taking medications to increase their well-being). The aim of this study is to explore whether combining DMPs with interventions to address these dimensions is feasible and has any impact on relevant outcomes in elderly patients with polypharmacy.

          Methods

          An explorative, cluster-randomized controlled trial with general practices as the unit of randomization will be conducted and accompanied by a process evaluation. Patients aged 70 years or older with at least three chronic conditions receiving at least three medications participating in at least one DMP will be included. The control group will receive DMP as usual. In the intervention group, GPs will conduct a spiritual needs assessment during the routinely planned DMP appointments and explore whether the patient has a need for more social contact or self-care. To enable GPs to react to such needs, several aids will be provided by the study: a) training of GPs in spiritual needs assessment and training of medical assistants in patient counseling regarding self-care and social activity; b) access to a summary of regional social offers for seniors; and c) information leaflets on nonpharmacological interventions (e.g., home remedies) to be applied by patients themselves to reduce frequent symptoms in old age. The primary outcome is health-related self-efficacy (using the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES-6G)). Secondary outcomes are general self-efficacy (using the General Self-Efficacy Scale (GSES)), physical and mental health (using the Short-Form Health Survey (SF-12)), patient activation (using the Patient Activation Measure (PAM)), medication adherence (using the Medication Adherence Report Scale (MARS)), beliefs in medicine (using the Beliefs About Medicines Questionnaire (BMQ)), satisfaction with GP care (using selected items of the European Project on Patient Evaluation of General Practice (EUROPEP)), social contacts (using the 6-item Lubben Social Network Scale (LSNS-6)), and loneliness (using the 11-item De-Jong-Gierveld Loneliness Scale (DJGS-11)). Interviews will be conducted to assess the mechanisms, feasibility, and acceptability of the interventions.

          Discussion

          If the interventions prove to be effective and feasible, large-scale implementation should be sought and evaluated by a confirmatory design.

          Trial registration

          German Clinical Trials Register (DRKS), DRKS00015696. Registered on 22 January 2019.

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          Most cited references 46

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          Effect of a self-management program on patients with chronic disease.

          For patients with chronic disease, there is growing interest in "self-management" programs that emphasize the patients' central role in managing their illness. A recent randomized clinical trial demonstrated the potential of self-management to improve health status and reduce health care utilization in patients with chronic diseases. To evaluate outcomes of a chronic disease self-management program in a real-world" setting. Before-after cohort study. Of the 613 patients from various Kaiser Permanente hospitals and clinics recruited for the study, 489 had complete baseline and follow-up data. The Chronic Disease Self-Management Program is a 7-week, small-group intervention attended by people with different chronic conditions. It is taught largely by peer instructors from a highly structured manual. The program is based on self-efficacy theory and emphasizes problem solving, decision making, and confidence building. Health behavior, self-efficacy (confidence in ability to deal with health problems), health status, and health care utilization, assessed at baseline and at 12 months by self-administered questionnaires. At 1 year, participants in the program experienced statistically significant improvements in health behaviors (exercise, cognitive symptom management, and communication with physicians), self-efficacy, and health status (fatigue, shortness of breath, pain, role function, depression, and health distress) and had fewer visits to the emergency department (ED) (0.4 visits in the 6 months prior to baseline, compared with 0.3 in the 6 months prior to follow-up; P = 0.05). There were slightly fewer outpatient visits to physicians and fewer days in hospital, but the differences were not statistically significant. Results were of about the same magnitude as those observed in a previous randomized, controlled trial. Program costs were estimated to be about $200 per participant. We replicated the results of our previous clinical trial of a chronic disease self-management program in a "real-world" setting. One year after exposure to the program, most patients experienced statistically significant improvements in a variety of health outcomes and had fewer ED visits.
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            Pain, depression, and fatigue: loneliness as a longitudinal risk factor.

            Pain, depression, and fatigue function as a symptom cluster and thus may share common risk factors. Interpersonal relationships clearly influence health, suggesting that loneliness may promote the development of the pain, depression, and fatigue symptom cluster. We hypothesized that loneliness would be related to concurrent symptom cluster levels and increases in symptom cluster levels over time.
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              Polypharmacy prevalence among older adults based on the survey of health, ageing and retirement in Europe

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                Author and article information

                Contributors
                cornelia.strassner@med.uni-heidelberg.de
                eckhard.frick@tum.de
                gabriele.stotz-ingenlath@tum.de
                Nicola.Buhlinger-Goepfarth@med.uni-heidelberg.de
                joachim.szecsenyi@med.uni-heidelberg.de
                krisam@imbi.uni-heidelberg.de
                friederike.schalhorn@med.uni-tuebingen.de
                jan.valentini@med.uni-tuebingen.de
                regina.stolz@med.uni-tuebingen.de
                stefanie.joos@med.uni-tuebingen.de
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                18 June 2019
                18 June 2019
                2019
                : 20
                Affiliations
                [1 ]ISNI 0000 0001 0328 4908, GRID grid.5253.1, Department of General Practice and Health Services Research, , University Hospital Heidelberg, ; Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany
                [2 ]ISNI 0000000123222966, GRID grid.6936.a, Department of Psychosomatic Medicine and Psychotherapy, Research Center Spiritual Care, , Technical University of Munich, ; Langerstr. 3, 81675 München, Germany
                [3 ]ISNI 0000 0001 0328 4908, GRID grid.5253.1, Department for Medical Biometry, Institute for Medical Biometry and Informatics, , University Hospital Heidelberg, ; Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany
                [4 ]ISNI 0000 0001 0196 8249, GRID grid.411544.1, Institute of General Practice and Interprofessional Care, , University Hospital Tübingen, ; Osianderstr. 5, 72076 Tübingen, Germany
                Article
                3435
                10.1186/s13063-019-3435-z
                6582494
                31215468
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100002347, Bundesministerium für Bildung und Forschung;
                Award ID: 01GL1803
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

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