Tablet-Based Outpatient Care for People With Dementia

Abstract. Most people with dementia (PwD) are treated on an outpatient basis, predominantly by general practitioners (GPs). This article provides a detailed protocol of a study aimed at developing and evaluating a tablet-based intervention to improve outpatient dementia care by fostering guideline-based treatment. A cluster-randomized controlled trial with an intervention group (tablet-based intervention) and a control group (treatment as usual plus information handbook) will be conducted. Clusters will be randomized at GP level. Primary outcome is defined as adherence to dementia guideline recommendations after 9 months. Secondary outcomes include various health outcomes assessed in PwD (e.g., quality of life) and informal caregivers (e.g., caregiver burden). Outcomes will be analyzed by an intention-to-treat analysis and using mixed models.

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The effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial

BMC Psychiatry ◽

10.1186/s12888-021-03376-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Eirin Kolberg ◽

Gunnhild Johnsen Hjetland ◽

Eirunn Thun ◽

Ståle Pallesen ◽

Inger Hilde Nordhus ◽

...

Keyword(s):

Nursing Home ◽

Controlled Trial ◽

Intervention Group ◽

Bright Light ◽

Light Treatment ◽

Control Group ◽

Randomized Controlled ◽

People With Dementia ◽

Affective Symptoms ◽

Cluster Randomized

Abstract Background The majority of people with dementia have behavioral and psychological symptoms of dementia (BPSD), including depression, anxiety and agitation. These may be elicited or aggravated by disrupted circadian rhythms. Bright light treatment (BLT) is a promising non-pharmacological approach to the management of BPSD, but previous research has yielded mixed results. Methods Eight nursing home dementia units (1 unit = 1 cluster) with 78 patients were invited to participate in a cluster randomized controlled trial from September 2017 to April 2018 investigating the effects of BLT on sleep and circadian rhythms (primary outcome) and BPSD (secondary outcome). Ceiling mounted LED-panels were installed in the intervention group (four units), providing light at 1000 lx and 6000 K (vertically at 1.2 m) between 10 a.m. and 3 p.m., with lower values in the mornings and evenings. Standard indoor light was used in the control group (four units). BPSD were assessed with The Cornell Scale for Depression in Dementia (CSDD) and the Neuropsychiatric Inventory Nursing Home Version (NPI-NH). Data collection took place at baseline and after 8, 16 and 24 weeks. Multilevel regression models with and without false discovery rate correction were used for the analysis, with baseline values and dementia stage entered as covariates. Results Sixty-nine patients were included in the study at baseline. Compared to the control group, the intervention group had a larger reduction on the composite scores of both the CSDD (95% CI = − 6.0 – − 0.3) and the NPI-NH (95% CI = − 2.2 – − 0.1), as well as on the NPI-NH Affect sub-syndrome, and the CSDD Mood related signs sub-scale at follow-up after 16 weeks. With FDR correction, the group difference was significant on the CSDD Mood related signs sub-scale (95% CI = − 2.7 – − 0.8) and the NPI-NH Affect sub-syndrome (95% CI = − 1.6 – − 0.2). No differences were found between conditions at weeks 8 or 24. Conclusion Compared to the control condition, affective symptoms were reduced after 16 weeks in the group receiving BLT, suggesting BLT may be beneficial for nursing home patients with dementia. Trial registration ClinicalTrials.gov Identifier: NCT03357328. Retrospectively registered on November 29, 2017.

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Effects on sleep from group activity with a robotic seal for nursing home residents with dementia: a cluster randomized controlled trial

International Psychogeriatrics ◽

10.1017/s1041610220001787 ◽

2020 ◽

pp. 1-12

Author(s):

Nina Jøranson ◽

Christine Olsen ◽

Giovanna Calogiuri ◽

Camilla Ihlebæk ◽

Ingeborg Pedersen

Keyword(s):

Sleep Disturbances ◽

Total Sleep Time ◽

Controlled Trial ◽

Intervention Group ◽

Sleep Time ◽

Group Activity ◽

Control Group ◽

Randomized Controlled ◽

People With Dementia ◽

Cluster Randomized

ABSTRACT Objectives: Sleep disturbances are common in people with dementia and increase with the severity of the disease. Sleep disturbances are complex and caused by several factors and are difficult to treat. There is a need for more robust and systematic studies dealing with sleep disturbances in older people with dementia. The aim of this study was to investigate effects from robot-assisted (Paro) group activity on sleep patterns in nursing home (NH) residents with dementia. Design: A cluster randomized controlled trial. Setting: Special care units in 10 NH in Norway. Participants: A total of 60 participants over 65 years with dementia were recruited. Thirty participants were recruited to the intervention group and 30 participants to the control group. Intervention: Participants participated in group activity with Paro for 30 minutes twice a week over 12 weeks or in control group (treatment as usual). Measurements: Sleep–wake patterns were assessed objectively by 7 days of wrist actigraphy before and after the intervention. Data were collected between March 2013 and September 2014. Data were analyzed using mixed models. Results: Positive effects on change in sleep were found in the intervention group as compared with the control group. The intervention group increased percentage of sleep efficiency, increased the amount of total sleep time and reduced number of nocturnal awakenings. In addition, a significant effect was found in reduced awakenings after sleep onset. Conclusions: Social stimulation through engaging group activity could contribute to improved sleep in people with dementia in NH. Increased sleep efficiency and total sleep time, in addition to fewer night awakenings, affect central indicators of good sleep quality across the life span. Improved sleep quality will also affect quality of life and comorbidities in vulnerable groups. We believe group activity with Paro to be an accessible and feasible non-pharmacological treatment for those who enjoy Paro.

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An Individual Cognitive Stimulation Therapy Application (iCST app) for People With Dementia and Carers: Protocol for a Feasibility Randomized Controlled Trial. (Preprint)

10.2196/preprints.24628 ◽

2020 ◽

Author(s):

Harleen Kaur Rai ◽

Justine Schneider ◽

Martin Orrell

Keyword(s):

Usual Care ◽

Controlled Trial ◽

Full Scale ◽

Cognitive Stimulation ◽

Control Group ◽

Treatment As Usual ◽

Randomized Controlled ◽

People With Dementia ◽

Individual Cognitive Stimulation Therapy

BACKGROUND There is a need for more resources to support the cognition and quality of life (QoL) of people with dementia. The individual Cognitive Stimulation Therapy application (iCST app) aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touch-screen technology. It has been developed according to the principles of CST and iCST which have previously shown to improve the cognition and QoL of people with dementia, and to benefit the relationship between the person with dementia and carer, while improving quality of the carer’s life. This study aims to evaluate the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app. OBJECTIVE To evaluate the feasibility of conducting a full-scale RCT with the iCST app compared to a treatment as usual (TAU) control group. METHODS A multi-centre, pragmatic, single blind, feasibility RCT with a treatment as usual (TAU) control group. This study aims to recruit 60 people with mild to moderate dementia and their informal carers as dyads. Both parties must be able to provide informed consent and participate in the intervention. Dyads will complete a baseline assessment which will include cognition and QoL measures, and will subsequently be randomized (1:1) to the iCST app intervention in addition to usual care, or to usual care only. All participants will be followed-up at 5 weeks and 11 weeks post-baseline. A range of feasibility outcomes will be assessed including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures. A sample of the experimental group will be invited to a semi-structured post-trial interview to further examine the experience of using the iCST app. RESULTS Recruitment began in November 2018 with 43 dyads recruited from primary and secondary care settings. Participants were randomized to the iCST app (n = 21) or TAU control group (n = 22) with a relatively low attrition rate throughout the study (n = 2). Dementia support groups and (online) research databases led to the majority of the referrals for the study. CONCLUSIONS This study will investigate whether it is feasible to conduct a full-scale RCT to evaluate the clinical effectiveness of the iCST app in comparison to usual care alone. In addition, it will further examine the usability of the iCST app. The data will provide information on potential modifications to be made to the intervention, study design, and study process. CLINICALTRIAL ClinicalTrials.gov, NCT03282877. Registered on 19 July 2017.

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

Western Journal of Nursing Research ◽

10.1177/01939459211020757 ◽

2021 ◽

pp. 019394592110207

Author(s):

Min Wen ◽

Yaqin Liang ◽

Qianqian Shen ◽

Juping Yu ◽

Pingping He ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Health Education ◽

Controlled Trial ◽

Coping Styles ◽

Intervention Group ◽

Control Group ◽

Convenience Sample ◽

Cluster Randomized ◽

And Coping

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.

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Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073689 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3689

Author(s):

Tzofnat Zadok-Gurman ◽

Ronit Jakobovich ◽

Eti Dvash ◽

Keren Zafrani ◽

Benjamin Rolnik ◽

...

Keyword(s):

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stressful Events ◽

Control Group ◽

Subjective Well Being ◽

Intention To Treat ◽

School Year ◽

Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

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

Canadian Respiratory Journal ◽

10.1155/2002/106262 ◽

2002 ◽

Vol 9 (4) ◽

pp. 253-259 ◽

Cited By ~ 21

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.

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A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126633 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6633

Author(s):

Winnie Wing Man Ng ◽

Anthony Siu Wo Wong ◽

Kin Cheung

Keyword(s):

Randomized Controlled Trial ◽

Healthy Eating ◽

Eating Habits ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Healthy Eating Habits ◽

Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

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Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

BMC Psychiatry ◽

10.1186/s12888-021-03280-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Roya Rahimi ◽

Shirin Hasanpour ◽

Mojgan. Mirghafourvand ◽

Khalil Esmaeilpour

Keyword(s):

Mental Health ◽

Confidence Interval ◽

Group Counseling ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

The Mean ◽

And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

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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)

10.2196/preprints.29640 ◽

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.

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