scholarly journals Measuring the Effects of Nurse-Practitioner (NP)-Led Care on Depression and Anxiety Levels in People with Multiple Sclerosis:  A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Penelope Smyth ◽  
Kaitlyn E Watson ◽  
Ross T. Tsuyuki
Keyword(s):  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Family Physicians ◽  
Anxiety And Depression ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Anxiety Levels

Abstract Background Canada has one of the highest rates of multiple sclerosis (MS) in the world. Treatments and supports for people with MS (PwMS) have become increasingly complex, requiring individualized and adaptive care. Specialized NPs provide advanced skills to those with complex medical conditions, with potential to enhance the health, functioning and quality of life for PwMS. This study aims to determine the effect of Nurse Practitioners (NPs) on depression and anxiety levels in PwMS. Methods We will perform a parallel randomized controlled trial. PwMS who are followed by general private-practice neurologists will be randomly assigned to the intervention group (NP-led care) or the ‘usual care’ control group (general neurologist or family physician and registered nurse support). In the intervention group, the NP will assess and provide care to the MS patient and their caregiver at a baseline visit, with 3-month and 6-month follow-up visits. PwMS in the control group will receive usual care provided by their community neurologists or family physicians with the standard assistance provided by registered nurses experienced in MS care. The primary outcome will be the difference in change in the patient’s anxiety and depression scores as measured by the validated Hospital Anxiety and Depression Scale (HADS) questionnaire at 3 months. Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to health-care professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire. Discussion Findings from this study will contribute to exploring benefits of advanced nursing practitioner interventions for PwMS followed by general neurologists and family physicians in a community setting. It will provide evidence of the benefits of NP-led care for PwMS and offer an alternative healthcare resource for management of MS. Trial Registration: Retrospectively registered June 26, 2020 at ClinicalTrials.gov (Unique protocol ID:Pro00069595);url: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009VEL&selectaction=Edit&uid=U00053N2&ts=4&cx=5oyfdk Protocol version: January 2017, version 1

scholarly journals Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

A randomized controlled trial to assess an anger management group programme

2009 ◽  
Vol 2 (1) ◽  
pp. 20-31 ◽  
Author(s):  
Farooq Naeem ◽  
Isabel Clarke ◽  
David Kingdon
Keyword(s):  
Anger Management ◽  
Controlled Trial ◽  
Management Programme ◽  
Anxiety And Depression ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Management Group ◽  
Cognitive Behavioural ◽  
Group Programme

AbstractWe describe the results of a randomized controlled trial to assess effectiveness of an anger management group programme, employing a cognitive behavioural framework that was run by the Psychology Service. The treatment group was compared with a control group on a waiting list. The trial was performed at the Southampton CBT Service. The treatment group received a cognitive behavioural anger management programme, initially based on Novaco's approach, but with further development of the motivational components. The control group received no treatment and was on a waiting list. The Novaco Anger Assessment Scale (NAS), State-Trait Anger Expression Inventory (STAXI), Evaluative Beliefs Scale (EBS), Hospital Anxiety and Depression Scale (HAD) and the Clinical Outcomes in Routine Evaluations (CORE) were used to measure anger, belief about self and others, anxiety and depression, and physical and psychological wellbeing. Clients in the anger management group showed statistically significant changes on STAXI, NAS, CORE and EBS subscales at the end of the therapy. The change in depression and anxiety on HAD (depression and anxiety) was not statistically significant. It was not possible to carry out analyses at follow-up due to high dropout rates. We concluded that an anger management programme using CBT was helpful in reducing anger and overall psychopathology.

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Mohammad Habibur Rahman Sarker ◽  
Michiko Moriyama ◽  
Harun Ur Rashid ◽  
Md Moshiur Rahman ◽  
Mohammod Jobayer Chisti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Kidney Disease ◽  
Randomized Controlled Trial ◽  
Kidney Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191

scholarly journals Efficacy and cost-utility of the eHealth application ‘Oncokompas’, supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Anouk S. Schuit ◽  
Karen Holtmaat ◽  
Nienke Hooghiemstra ◽  
Femke Jansen ◽  
Birgit I. Lissenberg-Witte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Utility ◽  
Control Group ◽  
Incurable Cancer ◽  
Randomized Controlled

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.

A randomized controlled trial of a brief educational and psychological intervention for patients presenting to a cardiac clinic with palpitation

2002 ◽  
Vol 32 (4) ◽  
pp. 699-706 ◽  
Author(s):  
R. MAYOU ◽  
D. SPRIGINGS ◽  
J. BIRKHEAD ◽  
J. PRICE
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Number Needed To Treat ◽  
Treatment Needs ◽  
Randomized Controlled

Background. We sought to determine whether a brief psycho-educational intervention reduced disability in patients with benign palpitation.Method. In a pragmatic randomized controlled trial within a cardiology clinic at a district general hospital, 80 consecutive patients diagnosed as having benign palpitation – either palpitation due to awareness of extrasystoles or sinus rhythm – with associated distress or disability were randomized to an intervention group (usual care plus nurse-delivered intervention based on cognitive-behavioural principles) or to a control group (usual care). Principal outcome was difference in proportion of participants with good or excellent researcher-rated activity levels at 3 months. Subsidiary outcomes were self-rated symptoms, distress and disability, researcher-rated unmet treatment needs.Results. The principal outcome showed a statistically and clinically significant benefit for the intervention group, with a number needed to treat of 3 (95% CIs 2 to 7). All but one subsidiary outcomes also showed a difference in favour of the intervention group, and several differences reached statistical significance. Significantly more of the control group had unmet treatment needs at 3 months.Conclusions. A brief, nurse-delivered, psycho-educational intervention, was an effective treatment for benign palpitation. Further evaluation, including assessment of cost-effectiveness, is needed. The findings have application to the care of patients presenting with other types of ‘unexplained’ medical symptoms.

scholarly journals The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sepideh Dinmohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
Leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Solution Focused

Abstract Background Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence. Methods A randomized controlled trial on 90 pregnant women was blocked into two intervention groups (n = 45) and a control (n = 45). The intervention group received six counseling sessions with a solution-focused approach. Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The tools were completed once before the intervention and again 6 weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant. Results A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps = 0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P = 0.001). Conclusion Solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence. Trial registration Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

scholarly journals Effects of a psychological nursing intervention on prevention of anxiety and depression in the postpartum period: a randomized controlled trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Hongling Liu ◽  
Yang Yang
Keyword(s):  
Postpartum Depression ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Behavior Intervention ◽  
Anxiety And Depression ◽  
Control Group ◽  
Cognitive Behavior ◽  
Randomized Controlled ◽  
Primiparous Women

Abstract Background Anxiety and postpartum depression are the most common psychological problems in women after delivery. Cognitive behavior intervention has been reported to have an effect in the therapy of postpartum depression. This research aimed to investigate whether cognitive behavior intervention could prevent the pathogenesis of postpartum depression in primiparous women. Methods In this randomized controlled trial, primiparous women who were prone to postpartum depression were recruited. Participates in the control group received routine postpartum care and those in the intervention group received both routine postpartum care and cognitive behavior intervention. Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Edinburgh Postpartum Depression Scale (EPDS) and Pittsburgh Sleep Quality Index (PSQI) were evaluated before and after the intervention. Results In the intervention group, the post-intervention scores of HAMA, HAMD, EPDS and PSQI were all significantly lower than the baseline scores (p = 0.034, p = 0.038, p = 0.004, p = 0.014, respectively). The proportion of participants with postpartum depression in the intervention group (11.5%) was significantly lower than the control group (24.3%) after the 6-week intervention. Participants in the intervention group were significantly more satisfied with the care than those in the control group (p = 0.032). Conclusion This research provided evidence that cognitive behavioral intervention in postpartum period could alleviate anxiety and depression in primiparous women, and inhibit the pathogenesis of postpartum depression. Trial registry This clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000040076).

scholarly journals Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

2020 ◽  
Author(s):  
Toshimi Takano ◽  
Ayako Matsuda ◽  
Noriko Ishizuka ◽  
Yukinori Ozaki ◽  
Koichi Suyama ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Emotional Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

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