Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: Secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

BMC Endocrine Disorders ◽

10.1186/s12902-020-00637-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Marjolein M. Iversen ◽

Jannicke Igland ◽

Hilde Smith-Strøm ◽

Truls Østbye ◽

Grethe S. Tell ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Foot Ulcer ◽

Well Being ◽

Foot Ulcers ◽

Control Group ◽

Patient Reported ◽

Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

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Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: Secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

10.21203/rs.3.rs-26938/v1 ◽

2020 ◽

Author(s):

Marjolein Memelink Iversen ◽

Jannicke Igland ◽

Hilde Smith-Strøm ◽

Truls Østbye ◽

Grethe Seppola Tell ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Foot Ulcer ◽

Well Being ◽

Foot Ulcers ◽

Control Group ◽

Patient Reported ◽

Reported Health

Abstract BACKGROUND Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. METHODS The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. RESULTS In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. CONCLUSIONS There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life.

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Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: Secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

10.21203/rs.3.rs-26938/v3 ◽

2020 ◽

Author(s):

Marjolein Memelink Iversen ◽

Jannicke Igland ◽

Hilde Smith-Strøm ◽

Truls Østbye ◽

Grethe Seppola Tell ◽

...

Keyword(s):

Quality Of Life ◽

Foot Ulcer ◽

Well Being ◽

Foot Ulcers ◽

Control Group ◽

Patient Reported ◽

Reported Health ◽

Cluster Randomized

Abstract BACKGROUND Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. METHODS The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. RESULTS In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. CONCLUSIONS There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration: clinicaltrials.gov, NCT01710774. Registered October 19th, 2012https://clinicaltrials.gov/ct2/show/NCT01710774?term=iversen+marjolein&draw=2&rank=1

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Effectiveness of Bibliotherapy on Quality of Life, Distress and Depression among Chronic Leg and Foot Ulcer

International Journal of Health Sciences and Research ◽

10.52403/ijhsr.20210412 ◽

2021 ◽

Vol 11 (4) ◽

pp. 93-101

Author(s):

Kirupa P. ◽

Shrinivasa Bhat

Keyword(s):

Quality Of Life ◽

Psychological Distress ◽

Usual Care ◽

Controlled Trial ◽

Foot Ulcer ◽

Control Group ◽

Distress Scale ◽

Interventional Group

Chronic leg and foot ulcer is an endangering health issue secondary to chronic venous insufficiency and Diabetes Mellitus. Apart from physical problems, psychological and emotional disturbances were arising as a co morbid conditions, which interfere with recovery and it could be managed by bibliotherapy. Study was focused to ascertain the effectiveness of bibliotherapy on quality of life, psychological distress and depression of these patients in an Indian context. Randomized controlled trial comparison with parallel group design was chosen. Interventional group received usual care along with bibliotherapy and control group received only usual care. Data were collected pretest, post test (1st week), I follow up (2nd week) and II follow up (3rd week). Cardiff wound impact schedule, Kessler’s psychological distress scale and Beck depression inventory were used. Bibliotherapy was prepared by the researcher based on literatures and qualitative study. Setting was limited to the selected hospitals in Mangalore, India. Power analysis estimated sample size as 50 in interventional group and 50 in control group. Findings imply that compared with controls, patients who received bibliotherapy demonstrated improved quality of life, reduced psychological distress and depression. Conclusively, it recommends psychosocial perspectives of these clients should not be neglected and supporting the therapeutic benefit of bibliotherapy in chronic physical illnesses to reduce mental health burden. Key words: Quality of life, Psychological Distress, Depression, Bibliotherapy, Leg and Foot ulcer.

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Significance of patient-reported outcomes for occupational resumption and quality of life after cardiac rehabilitation

European Heart Journal ◽

10.1093/ehjci/ehaa946.3107 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

A Salzwedel ◽

I Koran ◽

E Langheim ◽

A Schlitt ◽

J Nothroff ◽

...

Keyword(s):

Quality Of Life ◽

Physical Performance ◽

Well Being ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Funding Source ◽

Patient Reported ◽

Returning To Work

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance

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Long-Term Patient Satisfaction and Quality of Life After Breast-Conserving Therapy: A Prospective Study Using the BREAST-Q

Annals of Surgical Oncology ◽

10.1245/s10434-021-10377-4 ◽

2021 ◽

Author(s):

Ilona Stolpner ◽

Jörg Heil ◽

Fabian Riedel ◽

Markus Wallwiener ◽

Benedikt Schäfgen ◽

...

Keyword(s):

Quality Of Life ◽

Risk Factors ◽

Patient Satisfaction ◽

Repeated Measures ◽

Aesthetic Surgery ◽

Well Being ◽

Breast Conserving Therapy ◽

Patient Reported

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.

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A Proposal of an innovative program for informal caregivers of patients with mood disorders

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.943 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S603-S603

Author(s):

J. Cabral ◽

C. Barreto Carvalho ◽

P. Castilho Freitas ◽

C. Pato

Keyword(s):

Quality Of Life ◽

Mood Disorders ◽

Negative Impact ◽

Controlled Trial ◽

Informal Caregivers ◽

Well Being ◽

Control Group ◽

Compassion Focused Therapy ◽

The Impact

IntroductionIntervention with informal caregivers (IC) of psychiatric patients is internationally recognized as relevant and a priority. However, the existing responses in this area are still insufficient, especially regarding caregivers of individuals with mood disorders (MD). Mindfulness and compassion focused therapy have proven to be an effective approach in stress reduction and in improving emotional and social well-being of caregivers of patients with other conditions. However, no studies testing these new approaches in IC of patients with MD have been carried out. The objective of this work is to present a research project that aims to develop, implement and empirically test the effectiveness of an innovative group program to help informal caregivers of individuals with mood disorders to cope with the negative impact of the disease and reduce caregiver burdens.MethodsThe design of this experimental study to test the program's efficacy is a non-randomised controlled trial (nrct) with 12 months follow-up, with a mixed assessment methodology (quantitative and qualitative analysis). A sample of 60 informal caregivers of individuals with chronic MD will be constituted (n = 30 Control group; n= 30 Experimental group).ResultsWe expect the program to promote significant changes in participants in terms of several emotional variables (eg: burden, stress, resilience, compassion and quality of life).ConclusionsFurther efforts to continue studying the impact of interventions in caregivers should be carried out, as a way to improve the quality of life of caregivers and their ability to provide informal care to MD patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

10.2196/preprints.34409 ◽

2021 ◽

Author(s):

Kathleen P. O'Hora ◽

Raquel A. Osorno ◽

Dena Sadeghi-Bahmani ◽

Mateo Lopez ◽

Allison Morehouse ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

The Impact ◽

Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

10.21203/rs.2.461/v1 ◽

2019 ◽

Author(s):

Anna María Pálsdóttir ◽

Kjerstin Stigmar ◽

Bo Norrving ◽

Patrik Grahn ◽

Ingemar F Petersson ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Perceived Value ◽

Control Group ◽

Post Stroke ◽

Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

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Patient-reported outcomes in congenital cardiac disease: are they as good as you think they are?

Cardiology in the Young ◽

10.1017/s1047951110001216 ◽

2010 ◽

Vol 20 (S3) ◽

pp. 143-148 ◽

Cited By ~ 10

Author(s):

Philip Moons

Keyword(s):

Quality Of Life ◽

Cardiac Disease ◽

Patient Reported Outcomes ◽

Well Being ◽

Main Question ◽

Congenital Cardiac Disease ◽

Patient Reported ◽

Satisfaction With Treatment

AbstractPatient-reported outcomes are “any outcome based on data provided by patients or patient proxy as opposed to data provided from other sources”. Examples of patient-reported outcomes are quality of life, well-being, functional status, symptoms, adherence to treatment, satisfaction with treatment, and utility or preference-based measures. The main question of this manuscript is whether patient-reported outcomes in patients with congenital cardiac disease are as good as we think they are. In general, we could say yes, because numerous studies show that patients with congenital cardiac disease have an excellent quality of life. By contrast, we could say no, because patients generally overestimate their functioning, and up to two out of three patients are not compliant with the prescribed therapy or recommendations for follow-up. However, most importantly, we have to say that we do not know whether the patient-reported outcomes are good, because research with patient-reported outcomes in congenital cardiac disease is limited. Hence, patient-reported outcomes should be a priority on the agenda for research in the domain of congenital cardiac disease.

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