Low-grade inflammation and metabolic syndrome are seen in many chronic diseases, including rheumatoid arthritis (RA) and osteoarthritis (OA). Lifestyle interventions which combine different non-pharmacological therapies have shown synergizing effects in improving outcomes in patients with other chronic diseases or increased risk thereof, especially cardiovascular disease. For RA and metabolic syndrome-associated OA (MSOA), whole food plant-based diets (WFPDs) have shown promising results. A WFPD, however, had not yet been combined with other lifestyle interventions for RA and OA patients. In this protocol paper, we therefore present Plants for Joints, a multidisciplinary lifestyle program, based on a WFPD, exercise, and stress management. The objective is to study the effect of this program on disease activity in patients with RA (randomized controlled trial [RCT] 1), on a risk score for developing RA in patients with anti-citrullinated protein antibody (ACPA) positive arthralgia (RCT 2) and on pain, stiffness, and function in patients with MSOA (RCT 3), all in comparison with usual care.We designed three 16-week observer-blind RCTs with a waiting-list control group for patients with RA with low to moderate disease activity (2.6 ≤ Disease Activity Score [DAS28] ≤ 5.1, RCT 1, n = 80), for patients at risk for RA, defined by ACPA-positive arthralgia (RCT 2, n = 16) and for patients with metabolic syndrome and OA in the knee and/or hip (RCT 3, n = 80). After personal counseling on diet and exercise, participants join 10 group meetings with 6-12 other patients to receive theoretical and practical training on a WFPD, exercise, and stress management, while medication remains unchanged. The waiting-list control group receives usual care, while entering the program after the RCT. Primary outcomes are: difference in mean change between intervention and control groups within 16 weeks for the DAS28 in RA patients (RCT 1), the RA-risk score for ACPA positive arthralgia patients (RCT 2), and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score for MSOA patients (RCT 3). Continued adherence to the lifestyle program is measured in a two-year observational extension study.
Background: Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions.Methods/design: The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter.Discussion: Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia.Trial registration: Number Dutch Trial registration (Nederlands Trial Register): NTR3437.
Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
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Een goede voorbereiding is het halve werk, ook voor patiënten op de wachtlijst voor een chirurgische ingreep. We onderzoeken hoe de e-health-applicatie 'Beter Voorbereid' mensen helpt om sterker aan de start van een operatie te staan en zo sneller te herstellen.
Een goede voorbereiding is het halve werk, ook voor patiënten op de wachtlijst voor een chirurgische ingreep. We onderzoeken hoe de e-health-applicatie 'Beter Voorbereid' mensen helpt om sterker aan de start van een operatie te staan en zo sneller te herstellen.Doel De e-health-applicatie Beter Voorbereid helpt patiënten om zich voor te bereiden op hun operatie. Ons onderzoek richt zich op de effectiviteit, verbetering en implementatie van de app met vier werkpakketten: Het optimaliseren van de app op basis van ervaringen van patiënten en zorgverleners. Het vormen van een netwerk van eerste- en tweedelijns zorgverleners die zorg voorafgaande aan een operatie bieden. Het onderzoeken van de effectiviteit van de app. Het opstellen van een implementatieplan, inclusief businessmodellen, van de app Beter Voorbereid. Resultaten Dit onderzoek loopt momenteel. Na afronding vind je hier een samenvatting van de resultaten. Lees meer over dit project op beter-voorbereid.nl. Looptijd 01 november 2018 - 01 januari 2023 Aanpak Binnen het Amsterdam UMC, locatie VUmc en het UMC Utrecht is een pilot gehouden naar de studieprocedures en bruikbaarheid van de applicatie. Naar aanleiding van deze resultaten worden verbeteringen doorgevoerd in de procedures van het onderzoek en de inhoud van de applicatie. Vervolgens zal in vier ziekenhuizen een groot Randomized Controlled Trial (RCT) starten naar de effectiviteit van de applicatie. Naast het Amsterdam UMC en UMC Utrecht zal dit ook plaatsvinden bij het Dijklander ziekenhuis in Hoorn. In deze periode zal ook het onderzoek naar de bredere implementatie van de app 'Beter Voorbereid' worden uitgevoerd.
Effectiveness of Supported Education for students with mental health problems, an experimental study.The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow postsecondary education, which is a major channel in ourso ciety to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on educational and mental health outcomes of students with mental health problems at a university of applied sciences and a community college. To that end, a mixed methods design will be used. This design combines quantitative research (Randomized Controlled Trial) with qualitative research (focus groups, monitoring, interviews). 100 students recruited from the two educational institutes will be randomly allocated to either the intervention or control group.
