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

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.

Tablet-Based Outpatient Care for People With Dementia

GeroPsych ◽  
2019 ◽  
Vol 32 (3) ◽  
pp. 135-144 ◽  
Author(s):  
Sonia Lech ◽  
Julie L. O’Sullivan ◽  
Paul Gellert ◽  
Jan‐Niklas Voigt-Antons ◽  
Robert Greinacher ◽  
...  
Keyword(s):  
Group Treatment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Outpatient Basis ◽  
Treatment As Usual ◽  
Intention To Treat ◽  
People With Dementia ◽  
Cluster Randomized

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.

scholarly journals Individual Cognitive Stimulation Therapy in Alzheimer’s Disease: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Yu-chen Qiao ◽  
Hong Chang ◽  
Rui Wang ◽  
Jia-Mei Wang ◽  
Xiao-ying Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cognitive Stimulation ◽  
Control Group ◽  
Randomized Controlled ◽  
Cognitive Stimulation Therapy ◽  
Individual Cognitive Stimulation Therapy

Abstract Background: Individual cognitive stimulation therapy (ICST) can benefit cognition and quality of life for people with dementia, but the evidence for nurses-led individual cognitive stimulation interventions is limited.Objectives: The current study aimed to develop the process of planning and implementing ICST, and evaluate the effect of ICST on cognitive function and therapeutic effect in patients with mild Alzheimer’s disease (AD). Methods: It was a randomized controlled trial lasting for a half year. 38 patients with mild AD were recruited. The control group was given the “Individual Cognitive Stimulation Therapy Manual for AD” to deliver the sessions at home. The intervention group was given 90 minutes ‘cognitive stimulation sessions, completed up to three times weekly over 24 weeks. The outcomes were measured at baseline and 24weeks by the scales widely used in AD evaluation (MMSE, MoCA and ADL).Results: There were statistical significance between the two groups, especially the scores of memory, delayed memory in MMSE and scores of memory, delayed memory, immediate memory, attention in MoCA were significantly improved in the intervention group compared with control group. ICST show positive effects that may help preserve memory in mild AD.Conclusions: The ICST can improve the memory and attention cognitive domains in patients with mild AD. And the feedback from patient and caregiver in ICST was favorable.

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

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

scholarly journals Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

Trials ◽  
2012 ◽  
Vol 13 (1) ◽  
Author(s):  
Martin Orrell ◽  
Lauren A Yates ◽  
Alistair Burns ◽  
Ian Russell ◽  
Robert T Woods ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Cognitive Stimulation ◽  
Randomized Controlled ◽  
Cognitive Stimulation Therapy ◽  
Individual Cognitive Stimulation Therapy

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.

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