scholarly journals Effects of an interprofessional deprescribing intervention in Swiss nursing homes: the Individual Deprescribing Intervention (IDeI) randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Damien Cateau ◽  
Pierluigi Ballabeni ◽  
Anne Niquille
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Potentially Inappropriate Medications ◽  
Quality Circle ◽  
Physical Restraints ◽  
Inappropriate Medications

Abstract Background Deprescribing polypharmacy and potentially inappropriate medications (PIMs) has been shown to be beneficial to nursing home (NH) residents' health. Medication reviews are the most widely studied deprescribing intervention; in a previous trial, we showed that another intervention, a deprescribing-focused interprofessional quality circle, can reduce the use of inappropriate medications at the NH level. However, this intervention cannot account for the variety of the residents’ clinical situations. Therefore, we trialled a subsequent intervention in NH that enacted the quality circle intervention in the previous year. Methods In 7 NHs, the most heavily medicated residents were recruited and randomised to receive usual care or the intervention. The intervention was a pharmacist-led, deprescribing-focused medication review, followed by the creation of an individualised treatment modification plan in collaboration with nurses and physicians. Intervention’s effects were assessed after four months on the number and dose of PIMs used, quality of life, and safety outcomes (mortality, hospitalisations, falls, and use of physical restraints). Data were analysed using Poisson multivariate regression models. Results Sixty-two NH residents participated, falling short of the expected 100 participants; 4 died before initial data collection. Participants used a very high number of drugs (median 15, inter-quartile range [12-19]) and PIMs (median 5, IQR [3-7]) at baseline. The intervention did not reduce the number of PIMs prescribed to the participants; however, it significantly decreased their dose (incidence rate ratio 0.763, CI95 [0.594; 0.979]), in particular for chronic drugs (IRR 0.716, CI95 [0.546; 0.938]). No adverse effects were seen on mortality, hospitalisations, falls, and restraints use, but, in the intervention group, three participants experienced adverse events that required the reintroduction of withdrawn treatments, and a decrease in quality of life is possible. Conclusions As it did not reach its recruitment target, this trial should be seen as exploratory. Results indicate that, following a NH-level deprescribing intervention, a resident-level intervention can further reduce some aspects of PIMs use. Great attention must be paid to residents’ well-being when further developing such deprescribing interventions, as a possible reduction in quality of life was found in the intervention group, and some participants suffered adverse events following deprescribing. Trial registration ClinicalTrials.gov (NCT03688542, https://clinicaltrials.gov/ct2/show/NCT03688542), registered on 31.08.2018.

scholarly journals Effects of an interprofessional Quality Circle-Deprescribing Module (QC-DeMo) in Swiss nursing homes: a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Damien Cateau ◽  
Pierluigi Ballabeni ◽  
Anne Niquille
Keyword(s):  
Nursing Homes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Defined Daily Dose ◽  
Potentially Inappropriate Medications ◽  
Quality Circle ◽  
Linear Regression Models ◽  
Physical Restraints ◽  
Strong Trend

Abstract Background Potentially inappropriate medications (PIMs) are common among nursing homes (NH) residents, as is polypharmacy. Deprescribing has emerged in the past decade as a safe and effective way to reduce the use of PIMs and improve patient outcomes. However, effective deprescribing interventions are expensive, as they require specialised staff and a great amount of time for each resident. The Quality Circle Deprescribing Module (QC-DeMo) intervention was designed to be less resource-intensive than medication reviews, the current deprescribing gold standard. It consists of a QC session in which physicians, nurses, and pharmacists define a local deprescribing consensus for specific PIMs classes, which is then implemented in the NH. The intervention was trialled in a RCT, with the NH as unit of analysis. Methods After randomisation, intervention NHs enacted the QC-DeMo at the start of the follow-up year. The primary outcomes were the proportion of PIM galenic units and number of PIM defined daily dose per average resident and per day (DDD/res). PIM status was assessed by a combination of the 2015 Beers list and the Norwegian General Practice-Nursing Home criteria. Secondary outcomes were the number of DDD/res to avoid and to reevaluate; safety outcomes were mortality, hospitalisations, falls, and use of physical restraints. Outcomes were evaluated at follow-up using linear regression models, adjusting for the outcome baseline values. Results Fifty-eight NHs took part in the trial; no individual residents were recruited. The intervention did not reduce the primary outcomes, but a strong trend towards reduction was seen for the number of PIM DDD/res, which accounts for the doses used. PIM DDD/res to reevaluate were significantly reduced, mostly through a reduction in the use of proton-pump inhibitors. Falls and use of physical restraints were not affected, but a statistical interaction between the mission of the NH (geriatric unit or specialised dementia unit) and the intervention group was seen for mortality and hospitalisations. Conclusions The QC-DeMo intervention can reduce the use of some PIM classes, and could usefully complement other deprescribing interventions. Trial registration ClinicalTrials.gov (NCT03688542), registered on 26.09.2018, retrospectively registered.

AwareCare: a pilot randomized controlled trial of an awareness-based staff training intervention to improve quality of life for residents with severe dementia in long-term care settings

2012 ◽  
Vol 25 (1) ◽  
pp. 128-139 ◽  
Author(s):  
Linda Clare ◽  
Rhiannon Whitaker ◽  
Robert T Woods ◽  
Catherine Quinn ◽  
Hannah Jelley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Care Home ◽  
Intervention Group ◽  
Well Being ◽  
Care Staff ◽  
Control Group ◽  
Severe Dementia ◽  
Term Care

ABSTRACTBackground: The extent to which care home residents with severe dementia show awareness is influenced by the extent to which the environment provides opportunities for engagement and by the way in which care staff interact with them. We aimed to establish whether training care staff to observe and identify signs of awareness in residents with severe dementia resulted in improved quality of life for residents.Methods: In this pilot cluster randomized trial, care staff in four homes (n = 32) received training and supervision and carried out structured observations of residents using the AwareCare measure (n = 32) over an eight-week period, while staff in four control homes (n = 33) had no training with regard to their residents (n = 33) and no contact with the research team. The primary outcome was resident quality of life. Secondary outcomes were resident well-being, behavior and cognition, staff attitudes and well-being, and care practices in the home.Results: Following intervention, residents in the intervention group had significantly better quality of life as rated by family members than those in the control group, but care staff ratings of quality of life did not differ. There were no other significant between-group differences. Staff participating in the intervention identified benefits in terms of their understanding of residents’ needs.Conclusions: Staff were able to use the observational measure effectively and relatives of residents in the intervention homes perceived an improvement in their quality of life.

scholarly journals An assisted structured reflection on life events and life goals in advanced cancer patients: Outcomes of a randomized controlled trial (Life InSight Application (LISA) study)

2018 ◽  
Vol 33 (2) ◽  
pp. 221-231
Author(s):  
Renske Kruizinga ◽  
Michael Scherer-Rath ◽  
Johannes BAM Schilderman ◽  
Iris D Hartog ◽  
Jacoba PM Van Der Loos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Life Goals ◽  
Control Group ◽  
Incurable Cancer ◽  
Randomized Controlled ◽  
Spiritual Well Being

Background: Diagnosis and treatment of incurable cancer as a life-changing experience evokes difficult existential questions. Aim: A structured reflection could improve patients’ quality of life and spiritual well-being. We developed an interview model on life events and ultimate life goals and performed a randomized controlled trial to evaluate the effect thereof on quality of life and spiritual well-being. Design: The intervention group had two consultations with a spiritual counselor. The control group received care as usual. EORTC QLQ-C15-PAL and the FACIT-sp were administered at baseline and 2 and 4 months after baseline. Linear mixed model analysis was performed to test between-group differences over time. Participants: Adult patients with incurable cancer and a life expectancy ⩾6 months were randomized in a 1:1 ratio to the intervention or control group. Results: A total of 153 patients from six different hospitals were included: 77 in the intervention group and 76 in the control group. Quality of life and spiritual well-being did not significantly change over time between groups. The experience of Meaning/Peace was found to significantly influence quality of life ( β = 0.52, adj. R2 = 0.26) and satisfaction with life ( β = 0.61, adj. R2 = 0.37). Conclusion: Although our newly developed interview model was well perceived by patients, we were not able to demonstrate a significant difference in quality of life and spiritual well-being between groups. Future interventions by spiritual counselors aimed at improving quality of life, and spiritual well-being should focus on the provision of sources of meaning and peace.

scholarly journals The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial

2020 ◽  
Vol 34 (8) ◽  
pp. 1056-1071
Author(s):  
Line Kildal Bragstad ◽  
Ellen Gabrielsen Hjelle ◽  
Manuela Zucknick ◽  
Unni Sveen ◽  
Bente Thommessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Post Stroke ◽  
Related Quality ◽  
Health Related ◽  
The Mean

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group ( n = 166) or control group ( n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.

scholarly journals Mindfulness-based online intervention on mental health and quality of life among COVID-19 patients in China: an intervention design

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Ming-Yu Si ◽  
Wei-Jun Xiao ◽  
Chen Pan ◽  
Hao Wang ◽  
Yi-Man Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Physical Symptoms ◽  
Psychological Status ◽  
Control Group ◽  
Post Traumatic Stress

Abstract Background COVID-19 can lead to increased psychological symptoms such as post-traumatic stress disorder (PTSD), depression, and anxiety among patients with COVID-19. Based on the previous mindfulness-based interventions proved to be effective, this protocol reports a design of a randomized controlled trial aiming to explore the efficacy and possible mechanism of a mindful living with challenge (MLWC) intervention developed for COVID-19 survivors in alleviating their psychological problems caused by both the disease and the pandemic. Methods In April 2021, more than 1600 eligible participants from Hubei Province of China will be assigned 1:1 to an online MLWC intervention group or a waitlist control group. All participants will be asked to complete online questionnaires at baseline, post-program, and 3-month follow-up. The differences of mental health status (e.g. PTSD) and physical symptoms including fatigue and sleeplessness between the COVID-19 survivors who receiving the online MLWC intervention and the control group will be assessed. In addition, the possible mediators and moderators of the link between the MLWC intervention and target outcomes will be evaluated by related verified scales, such as the Five Facets Mindfulness Questionnaire. Data will be analyzed based on an intention-to-treat approach, and SPSS software will be used to perform statistical analysis. Discussion The efficacy and potential mechanism of MLWC intervention in improving the quality of life and psychological status of COVID-19 survivors in China are expected to be reported. Findings from this study will shed light on a novel and feasible model in improving the psychological well-being of people during such public health emergencies. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR2000037524; Registered on August 29, 2020, http://www.chictr.org.cn/showproj.aspx?proj=60034.

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.

scholarly journals Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

2005 ◽  
Vol 23 (25) ◽  
pp. 6027-6036 ◽  
Author(s):  
Patsy Yates ◽  
Sanchia Aranda ◽  
Maryanne Hargraves ◽  
Bev Mirolo ◽  
Alexandra Clavarino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Functional Assessment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Waist Circumference ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

scholarly journals A Mobile App for Thyroid Cancer Patients Aiming to Enhance Their Quality of Life: Protocol for a Quasiexperimental Interventional Pilot Study

10.2196/13409 ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. e13409 ◽  
Author(s):  
Evanthia Giannoula ◽  
Ioannis Iakovou ◽  
Ioannis Katsikavelas ◽  
Panagiotis Antoniou ◽  
Vasilios Raftopoulos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Thyroid Cancer ◽  
Intervention Group ◽  
Well Being ◽  
Good Prognosis ◽  
Mobile App ◽  
Information Platform ◽  
Therapeutic Procedures ◽  
Eortc Qlq

Background Thyroid cancer (TC) is one of the fastest growing cancers all over the world. Differentiated thyroid cancer (DTC) is the most frequent subtype of TC. When appropriate treatment is given, the prognosis for the patient is generally excellent. Despite the generally good prognosis of thyroid carcinomas, the symptoms may range from emotional to physical discomfort, depending on the thyroid hormone status, which can severely affect the patient. Moreover, the diagnostic and therapeutic procedures that DTC patients have to undergo, such as thyroidectomy and radioiodine therapy, significantly affect their mental and physical well-being. Often, the physician only addresses the favorable prognosis of DTC compared with other cancer types and neglects to assess issues related to the quality of life (QoL) of the patient; this was the reason we decided to design a mobile app for DTC patients and their caregivers. Objective The aim of this study is to research the feasibility and applicability of an mHealth app tailored to DTC patients, as reflected in their QoL. The main features of the developed app offer access to useful information about thyroid cancer, diagnostic tests, and the appropriate therapy administered to DTC patients. Methods Based on the existing literature, we created an up-to-date information platform regarding TC and especially DTC. In order to develop an effective app that can be implemented in current health care, we designed a section where the patient and physician can keep a medical record in an effort to enable access to such information at any time. Finally, we designed a user-friendly notification program, including pill prescription, follow-up tests, and doctor visit reminders in order to equally facilitate the lives of the patient and physician. Results Having developed this mobile app, we aim to conduct a pilot quasiexperimental interventional trial. Our intention is to enroll at least 30 TC patients and assign them to intervention or control groups. Both groups will receive standard care for treating and monitoring TC, and the intervention group will also receive and use the DTC app. TC patients’ QoL will be assessed for both control and intervention groups in order to examine the effectiveness of the DTC app. QoL will be assessed through the QoL core questionnaire European Organisation for Research and Treatment of Cancer (EORTC) QLQ-THY34 in combination with the EORTC QLQ-C30 questionnaire through quantitative statistical analysis. Conclusions The use of mHealth apps can play a significant role in patient education, disease self-management, remote monitoring of patients, and QoL improvement. However, the main limitation of the majority of existing studies has been the lack of assessing their usefulness as well as the absence of specific instruments to carry out this assessment. In light of those considerations, we developed a mobile app tailored to the needs of DTC patients. Furthermore, we evaluated its contribution to the QoL of the patients by using the EORTC QLQ-THY34 questionnaire, an accurate and safe instrument for the evaluation of the QoL in TC patients, while supporting future planned endeavors in the field. International Registered Report Identifier (IRRID) PRR1-10.2196/13409

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