| 1. |
- Ali, Lilas, 1981, et al.
(författare)
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Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial
- 2020
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:7
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: A core feature of chronic obstructive pulmonary disorder (COPD) and chronic heart failure (CHF) is that symptoms may change rapidly because of illness progression. Thus, these chronic conditions are associated with high rehospitalisation rates. Person-centred care (PCC) has been shown to have several benefits for patients with COPD or CHF (or both disorders) but it has not yet been investigated through e-health services. AIM: The project aims to evaluate the effects of PCC by a combined digital platform and structured telephone support for people with COPD and/or CHF. METHODS AND ANALYSIS: A randomised controlled trial with open, parallel groups which employs a participatory design process will be used. This project will also include process and health economic evaluation of the intervention. ETHICS AND DISSEMINATION: Ethical approval has been secured from the Regional Ethical Review Board in Gothenburg, Sweden (Dnr 063-17 and T063-18). Results will be presented at conferences and to healthcare professionals, participants and patient organisations. Findings will also be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03183817.
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| 2. |
- Berg, Marie, 1955, et al.
(författare)
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Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden
- 2019
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215 .- 1745-6215. ; 20:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: An important prerequisite for optimal healthcare is a secure, safe and comfortable environment. There is little research on how the physical design of birthing rooms affects labour, birth, childbirth experiences and birthing costs. This protocol outlines the design of a randomised controlled superiority trial (RCT) measuring and comparing effects and experiences of two types of birthing rooms, conducted in one labour ward in Sweden. METHODS/DESIGN: Following ethics approval, a study design was developed and tested for feasibility in a pilot study, which led to some important improvements for conducting the study. The main RCT started January 2019 and includes nulliparous women presenting to the labour ward in active, spontaneous labour and who understand either Swedish, Arabic, Somali or English. Those who consent are randomised on a 1:1 ratio to receive care either in a regular room (control group) or in a newly built birthing room designed with a person-centred approach and physical aspects (such as light, silencer, media installation offering programmed nature scenes with sound, bathtub, birth support tools) that are changeable according to a woman's wishes (intervention group). The primary efficacy endpoint is a composite score of four outcomes: no use of oxytocin for augmentation of labour; spontaneous vaginal births (i.e. no vaginal instrumental birth or caesarean section); normal postpartum blood loss (i.e. bleeding < 1000 ml); and a positive overall childbirth experience (7-10 on a scale of 1-10). To detect a difference in the composite score of 8% between the groups we need 1274 study participants (power of 80% with significance level 0.05). Secondary outcomes include: the four variables in the primary outcome; other physical outcomes of labour and birth; women's self-reported experiences (the birthing room, childbirth, fear of childbirth, health-related quality of life); and measurement of costs in relation to the hospital stay for mother and neonate. Additionally, an ethnographic study with participant observations will be conducted in both types of birthing rooms. DISCUSSION: The findings aim to guide the design of birthing rooms that contribute to optimal quality of hospital-based maternity care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03948815. Registered 13 May 2019-retrospectively registered.
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| 3. |
- Björk Brämberg, Elisabeth, et al.
(författare)
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Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA)
- 2018
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Ingår i: BMC Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background: Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. Methods: The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee's return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. Discussion: The study is a pragmatic trial which will include analyses of the intervention's effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care.
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| 4. |
- Blanck, Elin, et al.
(författare)
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Self‐efficacy and healthcare costs in patients with chronic heart failure or chronic obstructive pulmonary disease
- 2023
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Ingår i: ESC Heart Failure. - 2055-5822.
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Aims This study aims to explore possible associations between self‐efficacy and healthcare and drug expenditures (i.e. direct costs) in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD) in a study investigating the effects of person‐centred care delivered by telephone. Methods and results This exploratory analysis uses data from an open randomized controlled trial conducted between January 2015 and November 2016, providing remote person‐centred care by phone to patients with CHF, COPD, or both. Patients hospitalized due to worsening of CHF or COPD were eligible for the study. Randomization was based on a computer‐generated list, stratified for age ≥ 75 and diagnosis. At a 6 month follow‐up, 118 persons remained in a control group and 103 in an intervention group. The intervention group received person‐centred care by phone as an addition to usual care. Trial data were linked to register data on healthcare and drug use. Group‐based trajectory modelling was applied to identify trajectories for general self‐efficacy and direct costs. Next, associations between self‐efficacy trajectories and costs were assessed using regression analysis. Five trajectories were identified for general self‐efficacy, of which three indicated different levels of increasing or stable self‐efficacy, while two showed a decrease over time in self‐efficacy. Three trajectories were identified for costs, indicating a gradient from lower to higher accumulated costs. Increasing or stable self‐efficacy was associated with lower direct costs ( P = 0.0013). Conclusions The findings show that an increased or sustained self‐efficacy is associated with lower direct costs in patients with CHF or COPD. Person‐centred phone contacts used as an add‐on to usual care could result in lower direct costs for those with stable or increasing self‐efficacy.
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| 7. |
- Cederberg, Matilda, et al.
(författare)
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Effects of a Person-Centered eHealth Intervention for Patients on Sick Leave Due to Common Mental Disorders (PROMISE Study): Open Randomized Controlled Trial
- 2022
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Ingår i: Jmir Mental Health. - : JMIR Publications Inc.. - 2368-7959. ; 9:3
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Tidskriftsartikel (refereegranskat)abstract
- Background: Sick leave due to common mental disorders (CMDs) is a public health problem in several countries, including Sweden. Given that symptom relief does not necessarily correspond to return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care. Objective: The aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs. Methods: A randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform. Results: At the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave. Conclusions: A person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave.
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| 8. |
- Cederberg, Matilda, et al.
(författare)
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Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)
- 2020
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:9
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context. METHODS AND ANALYSIS: This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted. ETHICS AND DISSEMINATION: This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC. TRIAL REGISTRATION NUMBER: NCT03404583.
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| 9. |
- Ebrahimi, Zahra, et al.
(författare)
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Integrating Health Promotion with and for Older People - eHealth (IHOPe) – Evaluating remote integrated person-centred care - Protocol of a randomised controlled trial with effectiveness, health economic, and process evaluation
- 2023
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Ingår i: BMC Geriatrics. - : Springer Science and Business Media LLC. - 1471-2318. ; 23:1
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Background Healthcare and welfare systems worldwide are unprepared to accommodate the growing population of older people. Simultaneously, the cost of reactive care for older people is increasing. However, healthcare systems in many countries are reforming towards integrated and person-centred care with a focus on health promotion and proactive actions. The Integrating Health Promotion with and for Older People – eHealth (IHOPe) project aims to describe and evaluate a person-centred e-support intervention that promotes a sustainable partnership between community dwelling frail older people and health and social care professionals. Methods The IHOPe project is designed as a randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care and add-on person-centred care through telephone support and a digital platform. The primary outcome measure is a composite score of changes in general self-efficacy and the need for unscheduled hospital care. The project is conducted in Gothenburg, Sweden. At least 220 participants aged ≥ 75 years will be included after being screened using a frailty instrument. The study design, intervention components, digital platform, and questionnaires were developed in close collaboration with an advisory group of inter-professional researchers, stakeholders, clinicians, and older representatives. Data will mainly be collected through questionnaires at baseline and 3, 6, and 12 months after inclusion in the study. Recruitment is ongoing and should be completed during 2023. Data will be analysed using quantitative and qualitative methods. The evaluation will include effectiveness, process, and health economics. The study was approved by the Regional Ethical Review Board in Gothenburg, Sweden (Dnr 2019–05364, Dnr 2020–03550, Dnr 2021–03255). Discussion The findings will expand our knowledge of remotely integrated person-centred care for frail older people. Thereby, the IHOPe project is expected to fill highlighted knowledge gaps on intervention evaluations including the triad of person-centred, digital, and integrated care elements, as well as economic evaluations of remote health services for frail older people. The study is ongoing, and the results are not completed but if they turn out to be positive, implementation is not limited to time or location. Trial registration ClinicalTrial.gov: NCT04416815. Registered 07/06/2021.
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| 10. |
- Fors, Andreas, 1977, et al.
(författare)
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Effectiveness of person-centred care after acute coronary syndrome in relation to educational level: Subgroup analysis of a two-armed randomised controlled trial
- 2016
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Ingår i: International journal of cardiology. - : Elsevier BV. - 0167-5273 .- 1874-1754. ; 221, s. 957-962
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Tidskriftsartikel (refereegranskat)abstract
- AIM: The aim of this study was to evaluate the effects of person-centred care (PCC) after acute coronary syndrome (ACS) in relation to educational level of participants. METHOD: 199 Patients <75years with ACS were randomised to PCC plus usual care or usual care alone and followed for 6months from hospital to outpatient care and primary care. For the PCC group, patients and health care professionals co-created a PCC health plan reflecting both perspectives, which induced a continued collaboration in person-centred teams at each health care level. A composite score of changes that included general self-efficacy assessment, return to work or previous activity level, re-hospitalisation or death was used as outcome measure. RESULTS: In the group of patients without postsecondary education (n=90) the composite score showed a significant improvement in favour of the PCC intervention (n=40) vs. usual care (n=50) at six months (35.0%, n=14 vs. 16.0%, n=8; odds ratio (OR)=2.8, 95% confidence interval (CI): 1.0-7.7, P=0.041). In patients with postsecondary education (n=109), a non-significant difference in favour of the PCC intervention (n=54) vs. usual care (n=55) was observed in the composite score (13.0%, n=7 vs 3.6%, n=2; OR=3.9, 95% CI: 0.8-19.9, P=0.097). CONCLUSION: A PCC approach, which stresses the necessity of a patient-health care professional partnership, is beneficial in patients with low education after an ACS event. Because these patients have been identified as a vulnerable group in cardiac rehabilitation, we suggest that PCC can be integrated into conventional cardiac rehabilitation programmes to improve both equity in uptake and health outcomes. TRIAL REGISTRATION: Swedish registry, Researchweb.org, ID NR 65 791.
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