-
1.
DTEXT - text messaging intervention to improve outcomes of people with type 2 diabetes: protocol for randomised controlled trial and cost-effectiveness analysis.
Waller, K, Furber, S, Bauman, A, Allman-Farinelli, M, van den Dolder, P, Hayes, A, Facci, F, Franco, L, Webb, A, Moses, R, et al
BMC public health. 2019;(1):262
Abstract
BACKGROUND Diabetes prevalence is rapidly increasing, with type 2 diabetes predicted to be the leading contributor of non-communicable disease in Australia by 2020. It is anticipated that rates of type 2 diabetes will continue to increase if factors such as overweight and obesity, low physical activity and poor nutrition are not addressed. The majority of Australians with type 2 diabetes do not meet the guidelines for optimal diabetes management, and access to diabetes education is limited. This highlights the need for new interventions that can reduce existing barriers to diabetes education, attain greater population reach and support self-management strategies for people with type 2 diabetes. Mobile phone text messages have shown promising results as an intervention for people with chronic disease. They have the ability to achieve high levels of engagement and broad population reach, whilst requiring minimal resources. There is however, no evidence on the effect of text messaging to improve the health of people with type 2 diabetes in Australia. METHODS/DESIGN This randomised controlled trial aims to investigate if a 6 month text message intervention (DTEXT) can lead to improvements in glycated haemoglobin (HbA1c) and diabetes self-management among Australian residents in New South Wales (NSW) with type 2 diabetes. Community dwelling adults (n = 340) will be recruited with the primary outcome being change in HbA1c at 6 months. Secondary outcomes include behaviour change for diabetes self-management, self-efficacy, quality of life and intervention acceptability. An economic evaluation will be conducted using a funder plus patient perspective. DISCUSSION This study will provide evidence on the effectiveness and cost effectiveness of a text message intervention to reduce HbA1c and enhance self-management of type 2 diabetes in the Australian population. If successful, this intervention could be used as a model to complement and extend existing diabetes care in the Australian health care system. TRIAL REGISTRATION The study has been registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12617000416392 . Registered: 23 March 2017.
-
2.
Improving empowerment, motivation, and medical adherence in patients with poorly controlled type 2 diabetes: A randomized controlled trial of a patient-centered intervention.
Varming, AR, Rasmussen, LB, Husted, GR, Olesen, K, Grønnegaard, C, Willaing, I
Patient education and counseling. 2019;(12):2238-2245
Abstract
OBJECTIVE To test whether an intervention consisting of four patient-centered consultations improves glycemic control and self-management skills in patients with poorly regulated type 2 diabetes (T2DM), compared to a control group receiving usual care. METHODS Unblinded parallel randomized controlled trial including 97 adults diagnosed with T2DM ≥ 1 year and hemoglobin A1c (HbA1c) levels ≥ 8.0% (64 mmol/mol). Consultations incorporated tools supporting self-reflection, learning processes, and goal setting. Primary outcome was HbA1c. Secondary outcomes were autonomy support, motivation, self-management skills, and well-being. RESULTS Average HbA1c decreased slightly in both groups. Autonomy support and frequency of healthy eating were significantly higher in the intervention group. Most participants in the intervention group chose to set goals related to diet and physical exercise. Implementation of the intervention was inconsistent. CONCLUSION Despite increased autonomy support and individual goal-setting, the intervention was not superior to usual care in terms of glycemic control. More research is needed on how individual preferences and goals can be supported in practice to achieve sustainable behavior changes. PRACTICE IMPLICATIONS The intervention promoted participant engagement and supported exploration of participants' challenges and preferences. Further exploration of more flexible use of tools adapted to individual contexts is recommended.
-
3.
Adherence to osteoporosis therapy after an upper extremity fracture: a pre-specified substudy of the C-STOP randomized controlled trial.
McAlister, FA, Ye, C, Beaupre, LA, Rowe, BH, Johnson, JA, Bellerose, D, Hassan, I, Majumdar, SR
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2019;(1):127-134
Abstract
UNLABELLED Despite their proven efficacy for secondary fracture prevention, long-term adherence with oral bisphosphonates is poor. INTRODUCTION To compare the effectiveness of two interventions on long-term oral bisphosphonate adherence after an upper extremity fragility fracture. METHODS Community-dwelling participants 50 years or older with upper extremity fragility fractures not previously treated with bisphosphonates were randomized to either a multi-faceted patient and physician educational intervention (the active control arm) vs. a nurse-led case manager (the study arm). Primary outcome was adherence (taking > 80% of prescribed doses) with prescribed oral bisphosphonates at 12 months postfracture between groups; secondary outcomes included rates of primary non-adherence and 24-month adherence. We also compared quality of life between adherent and non-adherent patients. RESULTS By 12 months, adherence with the initially prescribed bisphosphonate was similar (p = 0.96) in both groups: 38/48 (79.2%) in the educational intervention group vs. 66/83 (79.5%) in the case manager arm. By 24 months, adherence rates were 67% (32/48) in the educational intervention group vs. 53% (43/81) in case managed patients (p = 0.13). Primary non-adherence was 6% (11 patients) in the educational intervention group and 12% (21 patients) in the case managed group (p = 0.07). Prior family history of osteoporosis (aOR 2.1, 95% CI 1.0 to 4.4) and being satisfied with current medical care (aOR 2.3, 95% CI 1.1 to 4.8) were associated with better adherence while lower income (aOR 0.2, 95% CI 0.1 to 0.6, for patients with income < $30,000 per annum) was associated with poorer rates of adherence. There were no differences in health-related quality of life scores at baseline or during follow-up between patients who were adherent and those who were not. CONCLUSION While both interventions achieved higher oral bisphosphonate adherence compared to previously reported adherence rates in the general population, primary non-adherence and long-term adherence to bisphosphonates were similar in both arms. Adherence was influenced by family history of osteoporosis, satisfaction with current medical care, and income. TRIAL REGISTRATION ClinicalTrials.gov : NCT01401556.
-
4.
Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial.
Gregoriano, C, Dieterle, T, Breitenstein, AL, Dürr, S, Baum, A, Giezendanner, S, Maier, S, Leuppi-Taegtmeyer, A, Arnet, I, Hersberger, KE, et al
Respiratory research. 2019;(1):273
Abstract
BACKGROUND Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. METHODS This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. RESULTS Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80-100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. CONCLUSION Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. TRIAL REGISTRATION ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.
-
5.
South Asians living in the UK and adherence to coronary heart disease medication: a mixed- method study.
Jalal, Z, Antoniou, S, Taylor, D, Paudyal, V, Finlay, K, Smith, F
International journal of clinical pharmacy. 2019;(1):122-130
-
-
Free full text
-
Abstract
Background The prevalence of coronary heart disease amongst South Asian population in the UK is higher compared to the general population. Objective This study sought to investigate beliefs and experiences of South Asian patients regarding coronary heart disease and medication taking behaviour. Setting A London Heart Attack Centre. Methods This mixed method study is part of an original pilot randomised study on 71 patients involving a pharmacy-led intervention to improve medication adherence in coronary heart disease patients. South Asian patients from the randomised study took part in qualitative semi-structured telephone interviews. Both South Asian and non-South Asian patients completed the questionnaire about adherence and beliefs regarding medicines using Morisky Scale and the Belief About Medicines Questionnaire-Specific at 2 weeks, 3 and 6 months. Outcome Patients' beliefs about coronary heart disease and medication adherence. Results Seventeen South Asian patients and 54 non-South Asian patients took part. Qualitative data from 14 South Asian patients showed that while some attributed coronary heart disease to genetic, family history for their illness, others attributed it to their dietary patterns and 'god's will' and that little could be done to prevent further episodes of coronary heart disease. On the Belief About Medicines Questionnaire-Specific in South Asian patients, beliefs about necessity of medicines outweighed concerns. South Asian patients (n = 17) showed a similar pattern of adherence compared to non-Asian patients (n = 54). Adherence decreased with time in both populations, adherence measured by Morisky Scale. Conclusion South Asian patients in this study often attributed coronary heart disease to additional causes besides the known risk factors. Future studies on their understanding of the importance of cultural context in their attitudes to prevention and lived experience of the disease is warranted.
-
6.
The impact of education on knowledge, adherence and quality of life among patients on haemodialysis.
Alikari, V, Tsironi, M, Matziou, V, Tzavella, F, Stathoulis, J, Babatsikou, F, Fradelos, E, Zyga, S
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2019;(1):73-83
Abstract
PURPOSE The purpose of the study was to assess the impact of an educational intervention on the level of knowledge, quality of life (QoL) and adherence to the treatment regimen among haemodialysis (HD) patients as well as to describe the association between these variables. METHODS In this quasi-experimental interventional study, 50 HD patients at a HD centre in Western Attica were randomly assigned into intervention (N = 25, received education and a booklet) and control (N = 25, received only the booklet) groups. Knowledge, adherence and quality of life were measured pre- and post-intervention using the Kidney Disease Questionnaire, the GR-Simplified Medication Adherence Questionnaire-HD and Missoula Vitas Quality of Life Index-15, respectively. The statistical analysis of the data was performed with the help of the Statistical Program SPSS version 19.0. The statistical significance level was set up at 0.05. RESULTS The increase of knowledge, adherence and QoL levels in the intervention group was significantly higher compared to the control group. There was no significant correlation between knowledge and adherence scores after the intervention. However, a significant positive correlation was found between the change in the overall QoL and the changes in the total adherence score as well as the adherence to the fluids and dietary behaviour. CONCLUSIONS An educational intervention can improve knowledge, adherence and QoL among HD patients. The increase of knowledge level is not associated with increased adherence. However, the increase of adherence may improve some dimensions of QoL.
-
7.
Patterns of prescription and discontinuation of contraceptives for Swedish women with obesity and normal-weight women.
Sundell, M, Ginstman, C, Månsson, A, Forslund, I, Brynhildsen, J
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception. 2019;(3):192-197
-
-
Free full text
-
Abstract
Purpose: This study aimed to explore the prescription of different contraceptive methods to Swedish women with obesity and to compare the pattern of prescription and adherence to treatment between this group and normal-weight women. Materials and methods: This study included 371 women with obesity and 744 matched normal-weight women, aged 18-40. Medical records were scrutinised for the period 1 January 2010 to 31 December 2014. The retrieved variables included: background characteristics, prescribed contraceptive methods, adverse effects, duration of treatment, reason for discontinuation and bleeding pattern. Result: Progestin-only pills were mainly prescribed to women with obesity (44% vs. 20%, p = 0.001) whereas combined hormonal contraception was mainly prescribed to normal-weight women (60% vs. 21%, p < 0.0001). Thirty-three percent vs. 25% (p = 0.003) discontinued their contraceptive method within 1 year. The most commonly declared reason for discontinuation was bleeding disturbance (14.7% vs. 9.6%, p = 0.008). Conclusion: The most commonly prescribed contraceptive method in women with obesity was progestin-only pills, but surprisingly many women with obesity were prescribed combined hormonal contraception despite current Swedish and European guidelines. Incident users with obesity were significantly more likely to discontinue their contraceptive method within the first year of the study period, compared with incident normal-weight users.
-
8.
Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol.
Mansell, H, Rosaasen, N, West-Thielke, P, Wichart, J, Daley, C, Mainra, R, Shoker, A, Liu, J, Blackburn, D
BMJ open. 2019;(3):e025495
Abstract
INTRODUCTION Non-adherence after kidney transplantation contributes to increased rejections, hospitalisations and healthcare expenditures. Although effective adherence interventions are sorely needed, increasing education and support to transplant recipients demands greater use of care providers' time and resources in a healthcare system that is stretched. The objective of this clinical trial is to determine the effectiveness of an electronically delivered video series and adherence behaviour contract on improving medication adherence to immunosuppressant medications. METHODS AND ANALYSIS A multicentre, parallel arm, randomised controlled trial will be conducted with four sites across North America (Saskatoon, Calgary, Halifax, Chicago). Adult patients will be randomised (1:1) to either the intervention (ie, home-based video education +behaviour contract plus usual care) or usual care alone. De novo transplant recipients will be enrolled prior to their hospital discharge and will be provided with electronic access to the video intervention (immediately) and adherence contract (1 month post-transplant). Follow-up electronic surveys will be provided at 3 and 12 months postenrolment. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report Basel Assessment of Adherence to Immunosuppressive medications and immunosuppressant levels. Secondary outcomes include the difference in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalised Self-efficacy Scale), Beliefs of Medicine Questionnaire (BMQ), quality of life (Short Form-12), patient satisfaction and cost utilisation. The study aims to recruit at least 200 participants across participating sites. ETHICS AND DISSEMINATION Ethical approval was obtained from the University of Saskatchewan Behavioural Ethics Committee (Beh 18-63), and all patients provide informed consent prior to participating. This educational intervention aims to improve information retention and self-efficacy, leading to improved medication adherence after kidney transplantation, at low cost, with little impact to existing healthcare personnel. If proven beneficial, delivery can be easily implemented into standard of care. TRIAL REGISTRATION NUMBER NCT03540121; Pre-results.
-
9.
A Pilot Randomized Controlled Trial Testing the Feasibility and Acceptability of a SystemCHANGE Intervention to Improve Medication Adherence in Older Adult Stroke Survivors.
Wessol, JL, Russell, CL, Olds, KE
The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses. 2019;(5):259-265
Abstract
BACKGROUND Adhering to an antithrombotic medication regimen is essential to reducing recurrent stroke in adult stroke survivors. The purpose of this study was to evaluate the feasibility and acceptability of the SystemCHANGE (SC) and attention control (AC) intervention in older adult, nonadherent ischemic stroke patients. METHODS A pilot randomized controlled trial was conducted to determine the feasibility and acceptability of an SC versus AC intervention in older adult, nonadherent stroke survivors in the management of antithrombotic medication. Participants were masked to group assignment. Stroke survivors 50 years or older, taking at least 1 once-a-day antithrombotic medication, were recruited from a Midwest Comprehensive Stroke Center-affiliated neurology office. They were screened electronically using the Medication Event Monitoring System for 2 months to determine baseline medication adherence. Nonadherent stroke survivors (medication adherence < 0.97) were randomized to SC or AC intervention and monitored for 3 months. SC focused on redesigning the interpersonal environmental system and daily routines. The AC group was provided education materials on stroke that consisted of stroke risk factor reduction, stroke facts, rehabilitation, and nutrition with the primary investigator. Participation and intervention experience interviews were evaluated for themes. RESULTS Thirty participants were recruited: median age was 64 years, 46.7% of them were male, and they took an average of 7.77 (SD, 3.191; range, 3-15) prescribed medications. The number of over-the-counter medications taken (excluding aspirin) on a regular basis averaged 1.9 (SD, 0.8; range, 1-4). Two participants were nonadherent and were randomized to the 2 arms. Both participants had positive feedback and were not inconvenienced by their participation in the study. Neither participant voiced concerns about the intervention, survey demands, time requirement, or completing the surveys on the primary investigator's laptop. CONCLUSION The SC and AC intervention protocols were feasible and acceptable to the participants in this study. Additional pilot testing is needed to further evaluate the intervention and its effect on medication adherence in this population.
-
10.
Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis.
Quittner, AL, Eakin, MN, Alpern, AN, Ridge, AK, McLean, KA, Bilderback, A, Criado, KK, Chung, SE, Riekert, KA
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 2019;(6):879-885
Abstract
BACKGROUND In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. METHODS iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11-20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. RESULTS Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25-100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. CONCLUSIONS The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.