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The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial.

ABSTRACT: Patients with RA (Rheumatoid Arthritis) are more sedentary than the general population. Reduction of Sedentary Behaviour (SB) has been suggested as a mean for improvement of health in patients with chronic diseases and mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in healthy populations. However, it remains unexplored whether it is valid for patients with RA also. Therefore, the aim of this trial is to investigate the efficacy of an individually tailored, theory-based motivational counseling intervention on reducing daily sitting time in sedentary patients with RA. Additionally, to explore whether a reduction in daily sitting time is associated with reduced pain and fatigue, self-reported physical function, self-efficacy, improved health-related quality of life (HR-QoL) and cardiovascular biomarker levels, and finally to assess the cost-effectiveness of the intervention.For this parallel group randomized trial, 150 patients with RA and at least 5 hours of sitting time per day, will be recruited from a rheumatology outpatient clinic, and block-randomized to the intervention group or the control group receiving usual care. The intervention includes: 1) individual motivational counseling (in total 3 sessions) on reduction of daily sitting time in combination with 2) individual Short Text Message Service (SMS) reminders over a 16-week intervention period. Primary outcome is change in daily sitting time (minutes) from baseline to 16 weeks measured objectively using an ActivPAL® Activity Monitor. Secondary outcomes include fatigue, pain, physical function, HR-QoL, self-efficacy, costs and cost-effectiveness. Furthermore, anthropometric measures will be included as well as measurement of blood pressure and serum lipids. All outcomes are assessed at baseline and repeated after 16 weeks. Follow-up assessments are made at 6 and 18 months post-intervention.The intervention is simple, non-invasive and may be implemented at low costs. If the study confirms the positive results expected, the intervention might be implemented in clinical practice and potentially transferred to other clinical populations.ClinicalTrial.gov registration number: NCT01969604 . Date of registration: 17 October 2013.

SUBMITTER: Esbensen BA

PROVIDER: S-EPMC4324661 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial.

Esbensen Bente Appel BA Thomsen Tanja T Hetland Merete L ML Beyer Nina N Midtgaard Julie J Løppenthin Katrine K Jennum Poul P Østergaard Mikkel M Sørensen Jan J Christensen Robin R Aadahl Mette M

Trials 20150127

<h4>Background</h4>Patients with RA (Rheumatoid Arthritis) are more sedentary than the general population. Reduction of Sedentary Behaviour (SB) has been suggested as a mean for improvement of health in patients with chronic diseases and mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in healthy populations. However, it remains unexplored whether it is valid for patients with RA also. Therefore, the aim of this trial is to ...[more]

PMID: 25623388

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Project description:Patients with rheumatoid arthritis (RA) spend a high proportion of their waking time in sedentary behaviour (SB) and have an increased risk of cardiovascular disease. Reduction of SB and increase in light intensity physical activity has been suggested as a means of improvement of health in patients with mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in sedentary populations. To evaluate descriptively the feasibility of recruitment, randomisation, outcome assessments, retention and the acceptability of an individually tailored, theory-based behavioural intervention targeting reduction in daily sitting time in patients with RA.A randomised, controlled trial with two parallel groups. RA patients >18 years of age and Health Assessment Questionnaire (HAQ) score?<?2.5 were consecutively invited and screened for daily leisure time sitting?>?4 h. The 16-week intervention included 1) three individual motivational counselling sessions and 2) individual text message reminders aimed at reducing daily sitting time. The control group was encouraged to maintain their usual lifestyles. Outcomes were assessed at baseline and after the 16 week intervention. Daily sitting time was measured using an ActivPAL3TM activity monitor. The study was not powered to show superiority; rather the objective was to focus on acceptability among patients and clinical health professionals.In total, 107 patients were invited and screened before 20 met eligibility criteria and consented; reasons for declining study participation were mostly flares, lack of time and co-morbidities. One patient from the control group dropped out before end of intervention (due to a RA flare). Intervention participants completed all counselling sessions. All procedures regarding implementation of the trial protocol were feasible. The daily sitting time was reduced on average by 0.30 h in the intervention group unlike the control group that tended to increase it by 0.15 h after 16 weeks.This study shows that an individually tailored behavioural intervention targeting reduction of SB was feasible and acceptable to patients with RA.The Danish Data Protection Agency (ref.nb. 711-1-08 - 20 March 2011), the Ethics Committee of the Capital Region of Denmark (ref.nb. H-2-2012-112- 17 October 2012), clinicaltrials.gov ( NCT01969604 - October 17 2013, retrospectively registered).

Project description:ObjectiveTo quantify the association between daily total sitting and all-cause mortality risk and to examine dose-response relationships with and without adjustment for moderate-to-vigorous physical activity.MethodsStudies published from 1989 to January 2013 were identified via searches of multiple databases, reference lists of systematic reviews on sitting and health, and from authors' personal literature databases. We included prospective cohort studies that had total daily sitting time as a quantitative exposure variable, all-cause mortality as the outcome and reported estimates of relative risk, or odds ratios or hazard ratios with 95% confidence intervals. Two authors independently extracted the data and summary estimates of associations were computed using random effects models.ResultsSix studies were included, involving data from 595,086 adults and 29,162 deaths over 3,565,569 person-years of follow-up. Study participants were mainly female, middle-aged or older adults from high-income countries; mean study quality score was 12/15 points. Associations between daily total sitting time and all-cause mortality were not linear. With physical activity adjustment, the spline model of best fit had dose-response HRs of 1.00 (95% CI: 0.98-1.03), 1.02 (95% CI: 0.99-1.05) and 1.05 (95% CI: 1.02-1.08) for every 1-hour increase in sitting time in intervals between 0-3, >3-7 and >7 h/day total sitting, respectively. This model estimated a 34% higher mortality risk for adults sitting 10 h/day, after taking physical activity into account. The overall weighted population attributable fraction for all-cause mortality for total daily sitting time was 5.9%, after adjusting for physical activity.ConclusionsHigher amounts of daily total sitting time are associated with greater risk of all-cause mortality and moderate-to-vigorous physical activity appears to attenuate the hazardous association. These findings provide a starting point for identifying a threshold on which to base clinical and public health recommendations for overall sitting time, in addition to physical activity guidelines.

Project description:In Cameroon, the National Tuberculosis Control Program that applies selective directly observed treatments faces difficulties in its implementation for a lack of resources, leading to only 65% of patients with sputum smear-positive pulmonary tuberculosis being cured after 6 months of treatment. This study aimed to evaluate the effectiveness of daily Short Message Service reminders to increase adherence and the proportion of adult tuberculosis patients cured after 6 months of treatment.A simple blinded, randomised controlled, multicentre study carried out in 12 Treatment and Diagnostic Centres of Yaoundé. The patients included were randomly assigned to two groups: patients in the intervention group received daily SMS reminders in addition to the usual treatment; those in the control group received the usual treatment only. The primary outcomes were the number and proportion of treatment success at 5 months, and the number and proportion of patients cured at 6 months. Data analysis was by intention to treat.Two hundred and seventy-nine participants were randomized into intervention group (n?=?137) and control group (n?=?142). At five months, there were 111 treatment success (81%) in the intervention group and 106 (74.6%) in the control group (OR?=?1.45 [0.81, 2.56]; p?=?0.203). At 6 months, there were 87 patients cured (63.5%) in the intervention group and 88 (62%) in the control group (OR?=?1.06 [0.65, 1.73]; p?=?0.791). The number of drop-outs at 6 months was 47 (34.3%) in intervention group, and 46 (32.4%) in the control group. 48.9% (23/47) and 39.1% (18/46) of these drop-outs were sputum-negative at 5 months. At three different appointments, there were no significant differences between the two groups in any secondary outcomes. Very high and similar satisfaction was found for general management of patients in both groups: 99.5 and 99.2% (p?=?0.41).Our study suggests that SMS reminders do not increase treatment success and cure proportions. However, the low proportion of patients cured at 6 month may be an underestimation due to a high dropout rate between the fifth and the sixth months of treatment. Future trials should focus on reducing the dropout rate.The trial was registered on the Pan-African Clinical Trials Registry ( PACTR201307000583416 of 22 July 2013) and the protocol was published.

Project description:PurposeThis quasi-experimental study examined the impact of height-adjustable desks in combination with prompts to break up prolonged sitting time during class time and identified social and motivational factors associated with breaking up sitting time among adolescents. Teachers' perceptions of strategies were also examined.MethodsOver 17 weeks, 1 classroom in a government secondary school in Melbourne, Australia, was equipped with 27 height-adjustable desks and prompts (posters and desk stickers) to break up classroom sitting time. Teachers received professional development in the use of the desks and prompts. One group of adolescents (n = 55) had 2-5 lessons/week using the height-adjustable desks in an intervention classroom, and a comparison group matched by year level and subject (n = 50) was taught in traditional "seated" classrooms. Adolescents wore an activPAL monitor at baseline (T0), 4 weeks (T1), and 17 weeks (T2) and completed a survey at T0 and T2. Six teachers participated in interviews at T2. Effect sizes were calculated (d).ResultsLinear mixed models found that, compared to the traditional "seated" classrooms, the adolescents in the intervention classroom had significantly lower sitting time (T1: -9.7 min/lesson, d = -0.96; T2: -6.7 min/lesson, d = -0.70) and time spent in sitting bouts >15 min (T2: -11.2 min/lesson, d = -0.62), and had significantly higher standing time (T1: 7.3 min/lesson, d = 0.84; T2: 5.8 min/lesson, d = 0.91), number of breaks from sitting (T1: 1.3 breaks/lesson, d = 0.49; T2: 1.8 breaks/lesson, d = 0.67), and stepping time (T1: 2.5 min/lesson, d = 0.66). Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).ConclusionThis intervention shows promise for targeting sitting behaviors in the classroom and indicates that incorporating social and motivational strategies may further enhance outcomes.

Project description:BackgroundDespite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality. At the same time, Slovakia has alarmingly low patients' adherence to medication intake. Studies have shown the efficiency of short messaging service (SMS) reminders to improve patients' adherence and health outcomes at low costs. Since SMS is popular among Slovaks, this approach may be feasible also in Slovakia. The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the standard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients.MethodsThe SPPA trial is a pragmatic randomized parallel group (1:1) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia. Trial pharmacies will be selected from all main regions of Slovakia. Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice. The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale (MMAS-8) and objective pill count rate. Secondary outcomes include: change in the MMAS-8; comparison of adherence rates using pill count; change in systolic blood pressure; and patient satisfaction. Also, direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out.DiscussionThe SPPA trial engages community pharmacists and mobile health (mHealth) technologies via evidence-based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges: high prevalence of hypertension; overconsumption of cardiovascular medicines; low adherence to medication treatment; and resulting uncontrolled blood pressure. The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients.Trial registrationClinicalTrials.gov, NCT03105687 . Registered on 07 March 2017.

Dataset Information

The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial.

Publications

The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial.

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