Therapy Adherence Research Articles

Assessing the Effectiveness of Multilevel Intervention Sequences on "Tension" Among Men Living with HIV: A Randomized-Control Trial.

Tension (often times called "Tenshun" in Hindi) is a cultural expression used to convey feelings of distress and common mental disorders in India and among South Asia communities. This study compared the effectiveness of different intervention sequences in reducing tension among alcohol-consuming men living with HIV in India. This secondary data analysis paper utilized data from a randomized trial study titled "Alcohol and Antiretroviral Therapy (ART) Adherence: Assessment, Intervention, and Modeling in India." The multilevel interventions, including individual counseling (IC), group intervention (GI), and collective advocacy (CA), were conducted sequentially over three cycles at three ART centers. Additionally, another ART center, serving as a pilot site, received all three interventions simultaneously in the final cycle. Participants completed surveys assessing demographic characteristics, tension, and other variables including HIV stigma, a 4-day ART adherence, HIV symptoms, and depressive symptoms at four time points: baseline, 9months, 18months, and 24months. General linear mixed models were employed to assess the intervention effects on tension. Out of 940 participants, 666 reported experiencing tension, including 54% reporting high tension. At site 1, the GI-CA-IC sequence resulted in a slope of -0.06, indicating that this sequence reduced tension from T1 to T4 compared to the control group (p < 0.01). Additionally, the pilot site where the intervention package was conducted simultaneously had a slope of -0.06, indicating that the intervention package also reduced tension compared to the control group (p < 0.01). Conversely, the CA-IC-GI sequence resulted in a slope of 0.07, indicating that this sequence resulted in significantly higher tension levels than the control group (p = 0.008) contrary to the expectation that the sequence would reduce tension. This study contributes valuable insights on the issue of tension among alcohol-consuming men living with HIV. The significant reduction in tension observed at the site using the GI-CA-IC sequence, which began with a group intervention, underscores the importance of intervention order and the importance of group intervention within multilevel intervention programs for tension reduction. Further research is needed to validate these observations and broaden our understanding of effective tension management strategies among people living with HIV in diverse settings. URL: clinicaltrials.gov. NCT03746457.

Comprehensive real time remote monitoring for Parkinson’s disease using Quantitative DigitoGraphy

People with Parkinson’s disease (PWP) face critical challenges, including lack of access to neurological care, inadequate measurement and communication of motor symptoms, and suboptimal medication management and compliance. We have developed QDG-Care: a comprehensive connected care platform for Parkinson’s disease (PD) that delivers validated, quantitative metrics of all motor signs in PD in real time, monitors the effects of adjusting therapy and medication adherence and is accessible in the electronic health record. In this article, we describe the design and engineering of all components of QDG-Care, including the development and utility of the QDG Mobility and Tremor Severity Scores. We present the preliminary results and insights from an at-home trial using QDG-Care. QDG technology has enormous potential to improve access to, equity of, and quality of care for PWP, and improve compliance with complex time-critical medication regimens. It will enable rapid “Go-NoGo” decisions for new therapeutics by providing high-resolution data that require fewer participants at lower cost and allow more diverse recruitment.

HIV and intersectional stigma among people living with HIV and healthcare workers and antiretroviral therapy adherence in the Dominican Republic.

HIV-related stigma, discrimination, and social marginalization undermines optimal HIV care outcomes. More research examining the impact of HIV-related stigma, discrimination, other interlocking forms of oppression, and antiretroviral therapy (ART) adherence is needed to optimize HIV treatment programming. This study uses data from two clinics in the Dominican Republic to examine client and healthcare worker (HCW) perceptions of HIV and intersectional stigmas among people living with HIV. Surveys exploring demographics, HIV-related stigma, various dimensions of discrimination (race/ethnicity, HIV status, sexual orientation), healthcare engagement, and medication adherence were collected from 148 clients and 131 HCWs. Analysis of variance was conducted to examine differences in stigma by clinic and logistic regressions were used to determine predictors of optimal client medication adherence. Perceived discrimination in healthcare facilities due to clients' sexual orientation retained significance in crude and multivariable logistic regression models and was negatively associated with ART adherence (aOR:0.79; 95% CI:0.66, 0.95). Findings highlight the importance of implementing strategies to address stigma, discrimination, and social marginalization, particularly within healthcare facilities.

Therapy Adherence, Comorbidities and Recurrent Hospitalitation in Coronary Heart Disease Patient

Therapy Adherence, Comorbidities and Recurrent Hospitalitation in Coronary Heart Disease Patient

Utilization and Perceptions of Hydroxyurea Therapy Among Adult Patients With Sickle Cell Disease in Al Ahsa, Saudi Arabia: A Cross-Sectional Study.

Sickle cell disease (SCD) is a prevalent genetic disorder characterized by abnormal hemoglobin formation, resulting in severe complications. Hydroxyurea (HU) therapy has demonstrated efficacy in reducing SCD-related complications; however, its utilization patterns and patient perceptions remain underexplored, particularly in the Al Ahsa region of Saudi Arabia. This cross-sectional study aimed to assess the prevalence of HU usage among adult patients with SCD in Al Ahsa; identify the barriers to starting, maintaining, and discontinuing HU therapy; and evaluate the patient-reported outcomes associated with its use. Data were collected through face-to-face surveys and medical record reviews of adult SCD patients attending outpatient clinics in the Hereditary Blood Diseases Center of Al Ahsa, Saudi Arabia, between December 2023 and March 2024. Descriptive statistics and inferential analyses were performed using SPSS version 26. A total of 345 adult SCD patients were included, with a mean age of 34.12 ± 11.1 years. Most participants were male (58.6%) and unmarried (55.4%). HU utilization was reported by 57.1% of the participants, with the highest adherence observed among older age groups (p = 0.001). Significant improvements in pain severity, hospitalization rates, and quality of life were reported among HU users (p < 0.001). Common barriers to HU use included concerns about side effects, lack of medical justification, and absence of medical advice. This study provides valuable insights into theutilization and perceptions of HU therapy among adults with SCDin Al Ahsa, Saudi Arabia. Addressing identified barriers and promoting patient education are crucial for optimizing therapy adherence and improving clinical outcomes in this population.

Psychometric evaluation of the Adherence to Refills and Medications Scale (ARMS) in Australians living with gout

This study aimed to examine psychometric properties of the Adherence to Refills and Medications Scale (ARMS) in people with gout. We conducted exploratory factor analysis (EFA) and tested internal consistency (ordinal and Cronbach’s alpha coefficients) and agreement (intraclass correlation coefficient (2,1)) in ARMS scores across three timepoints (baseline, 6, and 12 months) in 487 people with gout. The Kruskal–Wallis test, Spearman’s rank, Kendall’s tau-b correlations, and logistic regression were used to examine the criterion-related validity of the ARMS and factors associated with the ARMS. EFA suggested a one-factor structure, explaining 43.2% of total variance. High internal consistency (ordinal alpha = 0.902 at baseline) and moderate agreement in ARMS scores over time (ICCs > 0.5; p < 0.001) were observed. Lower ARMS scores (indicating better adherence) predicted achieving target serum urate (OR, 0.89; 95% CI, 0.83–0.95; p < 0.001), but not urate-lowering therapy (ULT) adherence (Proportion of Days Covered (PDC) ≥ 80%) (OR, 0.93; 95% CI, 0.81–1.05; p = 0.261). Negative correlations between ARMS and PDC were not statistically significant (Kendall’s tau-b, r = − 0.126, p = 0.078; Spearman’s rho = − 0.173, p < 0.073). Differences in median ARMS scores (IQR) of 16 (14–20), 13 (12–15), and 17.5 (15–21) in three groups of participants who reported (1) not taking ULT, (2) taking ULT and adherent, and (3) taking ULT but not adherent, respectively, were statistically significant (p < 0.001). Age was the only patient factor independently associated with optimal adherence (ARMS score = 12) (OR, 1.91; 95% CI, 1.50–2.43; p < 0.001). The ARMS is a reliable and valid measure of medication adherence behaviours in people with gout, justifying its use in gout medication adherence research.Key Points• Valid, practical, and efficient methods of measuring adherence to medications are needed in people with gout.• Commonly used medication adherence questionnaires have limited validity or have not been validated in people with gout.• The Adherence to Refills and Medications Scale (ARMS) has been proven valid and practical in many chronic illnesses but has not been validated in people with gout.• We showed the ARMS is valid and reliable for use in people with gout.

Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension.

This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant. A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry. Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003). The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant. ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.

Care Pathway of Venous Thromboembolism (VTE)

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are prevalent diseases associated with high morbidity and mortality. This study aimed to explore the experiences and needs of patients and physicians within the care pathway of DVT and PE. Ensuring care pathways match patients’ and physicians’ needs, could positively impact therapy adherence and patient satisfaction. Participants were 34 patients and 18 physicians. The qualitative focus groups occurred face-to-face and on an online discussion forum, utilising a predefined topic list. Focus group transcripts were analysed through deductive thematic analysis. Patients and physicians shared similar needs and experiences with information provision and shared decision making. Differences emerged regarding the adequacy of information provided, follow-up and monitoring of residual complaints, and personalised care. Generally, patients expressed higher levels of dissatisfaction compared to physicians. Our findings reveal a disparity between the perceived quality of care by physicians and patients, with patients expressing needs that diverge from physicians' assumptions. Patients need psychological support following DVT and PE, whereas physicians focus on physical recovery. Treatment intensity could be adjusted to align with patients' preferences. These findings highlight the potential for optimising care for patients and ensuring better outcomes in the management of DVT and PE.

Advances in nucleic acid-targeted therapies for cardiovascular disease prevention.

Nucleic acid-based therapies are being rapidly developed for prevention and management of cardiovascular diseases (CVD). Remarkable advancements have been achieved in the delivery, safety, and effectiveness of these therapeutics in the past decade. These therapies can also modulate therapeutic targets that cannot be sufficiently addressed using traditional drugs or antibodies. Among the nucleic acid-targeted therapeutics under development for CVD prevention are RNA-targeted approaches, including antisense oligonucleotides (ASO), small interfering RNAs (siRNA), and novel genome editing techniques. Genetic studies have identified potential therapeutic targets that are suggested to play a causative role in development and progression of CVD. RNA- and DNA-targeted therapeutics can be particularly well delivered to the liver, where atherogenic lipoproteins and angiotensinogen (AGT) are produced. Current targets in lipid metabolism include proprotein convertase subtilisin/kexin type 9 (PCSK9), apolipoprotein A (ApoA), apolipoprotein C3 (ApoC3), angiopoietin-like 3 (ANGPTL3). Several large-scale clinical development programs for nucleic acid-targeted therapies in cardiovascular prevention are under way, which may also be attractive from a therapy adherence point of view, given the long action of these therapeutics. In addition to genome editing, the concept of gene transfer is presently under assessment in preclinical and clinical investigations as a potential approach for addressing low-density lipoprotein receptor deficiency. Furthermore, ongoing research is exploring the use of RNA-targeted therapies to treat arterial hypertension by reducing hepatic angiotensinogen (AGT) production. This review summarizes the rapid translation of siRNA and ASO therapeutics as well as gene editing into clinical studies to treat dyslipidemia and arterial hypertension for CVD prevention. It also outlines potential innovative therapeutic options that are likely relevant to the future of cardiovascular medicine.

BEST FOR CAN – bringing empirically supported treatments to children and adolescents after child abuse and neglect: update to the study protocol

ABSTRACT Background: The implementation trial BESTFORCAN aims to evaluate the dissemination of Trauma-Focused Behavioural Therapy (TF-CBT) for children and adolescents in Germany with posttraumatic stress symptoms (PTSS) after child abuse and neglect (CAN) with a focus on supervision. Objective: This update to the study protocol outlines changes made due to practical reasons in the course of the ongoing trial while maintaining methodological quality. Method: The amendments to the original study protocol comprise (1) a more refined operationalisation of the primary outcome sufficiently adherent TF-CBT therapy (SATT), (2) changes in the study sites and (3) additional inclusion of one post-gradual psychotherapy training institute. Discussion: The adaptions to the original study protocol ensured high methodological quality through the transparent presentation of protocol modification: ensuring the recruitment of participating psychotherapists in training by including a further post-gradual training institute as well as an adaption of the measurement of SATT with high external validity. The objectives, diagnostic set, and secondary outcomes remained unimpaired by the amendment. Therefore, we expect the trial to provide evidence for the effect of model-specific trauma-focused supervision on the implementation outcomes of TF-CBT as compared to supervision as usual. Trial registration: German Clinical Trials Register identifier: DRKS00020516..

Preoperative Crohn's Disease Exclusion Diet and Exclusive Enteral Nutrition in Adults with Crohn's Disease: A Feasibility Randomised Controlled Trial.

Preoperative exclusive enteral nutrition (EEN) improves nutritional status, reduces intestinal inflammation, and likely improves surgical outcomes. Crohn's disease exclusion diet with partial enteral nutrition (CDED) also reduces intestinal inflammation but its safety preoperatively is unknown. This single-blinded, multicentre, randomised controlled trial of three preoperative nutritional therapies aimed to assess the feasibility of recruiting and retaining patients and collecting primary and secondary effectiveness outcomes. Adults undergoing elective Crohn's disease surgery with a body mass index (BMI) > 18.5 kg/m2 and without significant weight loss were eligible to participate. Patients were randomly assigned to six weeks of preoperative EEN, CDED, or standard care. Feasibility, nutritional, radiological, and surgical outcomes were recorded. Over 18 months, 48 patients were screened, 17 (35%) were randomised, and 13/17 (76%) patients were retained in the intervention phase. It was feasible to collect primary and secondary effectiveness data; at day 30, three patients had Clavien Dindo Grade 2 complications, and 10 had no complications. Nutritional therapy adherence of patients retained in the study was high. Recruitment and retention of patients who need elective Crohn's disease surgery for preoperative nutritional therapy is possible, although a shorter duration may improve EEN completion. The impact on surgical outcomes should be assessed in a larger study.

Racial Disparity in Adherence to Endocrine Therapy among Women with Early-Stage Hormone Receptor Positive Breast Cancer: An Analysis of Arkansas All-Payers Claims Database

Introduction/BackgroundTo assess racial/ethnic disparities in endocrine therapy (ET) adherence among women with breast cancer. Materials and MethodsA retrospective cohort study of Arkansas All-Payer Claims Database (APCD) linked to Arkansas Cancer Registry (ACR). Women with stages 0-3 HR+ breast cancer diagnosed in 2013-2017 were followed from cancer diagnosis for a year to determine ET initiation. Among women who initiated ETs within 1 year of diagnosis, we assessed first-year compliance (proportion of days covered ≥ 0.8) and followed them for 5 years, censoring at death, end of data availability (December 21, 2019), or disenrollment from insurance coverage, whichever occurred first, to determine time to discontinuation. Regression analysis was conducted to determine racial/ethnic disparities in ET use adjusting for patients demographic, clinical, tumor characteristics and county-level socioeconomic factors. ResultsAmong women with continuous insurance coverage, 81% initiated ET within 1 year of diagnosis; 80% were compliant in the first year of ET use and 27.4% discontinued ET by year 5 among those who initiated ET in the first year. There were no racial/ethnic differences in ET initiation or first-year compliance adjusting for covariates. NHB women were significantly less likely to discontinue ET within 5 years after ET initiation compared to NHW women after (HR, 95% CI, 0.76, 0.58-0.98; P = .035). ConclusionAfter adjusting for patients’ and tumor characteristics, there were no racial/ethnic differences in ET initiation within 1 year of diagnosis and ET compliance within first year of ET use. However, NHB women were less likely to discontinue ET within 5 years of initiation.

Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial

BackgroundRural African people living with HIV face significant challenges in entering and remaining in HIV care. In rural Uganda, for example, there is a threefold higher prevalence of HIV compared to the national average and lower engagement throughout the HIV continuum of care. There is an urgent need for appropriate interventions to improve entry and retention in HIV care for rural Ugandans with HIV. Though many adults living with HIV in rural areas prioritize seeking care services from traditional healers over formal clinical services, healers have not been integrated into HIV care programs. The Omuyambi trial is investigating the effectiveness of psychosocial support delivered by traditional healers as an adjunct to standard HIV care versus standard clinic-based HIV care alone. Additionally, we are evaluating the implementation process and outcomes, following the Consolidated Framework for Implementation Research.MethodsThis cluster randomized hybrid type 1 effectiveness-implementation trial will be conducted among 44 traditional healers in two districts of southwestern Uganda. Healers were randomized 1:1 into study arms, where healers in the intervention arm will provide 12 months of psychosocial support to adults with unsuppressed HIV viral loads receiving care at their practices. A total of 650 adults with unsuppressed HIV viral loads will be recruited from healer clusters in the Mbarara and Rwampara districts. The primary study outcome is HIV viral load measured at 12 months after enrollment, which will be analyzed by intention-to-treat. Secondary clinical outcome measures include (re)initiation of HIV care, antiretroviral therapy adherence, and retention in care. The implementation outcomes of adoption, fidelity, appropriateness, and acceptability will be evaluated through key informant interviews and structured surveys at baseline, 3, 9, 12, and 24 months. Sustainability will be measured through HIV viral load measurements at 24 months following enrollment.DiscussionThe Omuyambi trial is evaluating an approach that could improve HIV outcomes by incorporating previously overlooked community lay supporters into the HIV cascade of care. These findings could provide effectiveness and implementation evidence to guide the development of policies and programs aimed at improving HIV outcomes in rural Uganda and other countries where healers play an essential role in community health.Trial registrationClinicalTrials.gov NCT05943548. Registered on July 5, 2023. The current protocol version is 4.0 (September 29, 2023).

Effect of Educational Module on Severity of Dyspnea and Inhalation Therapy Adherence among Patients with Bronchial Asthma

Effect of Educational Module on Severity of Dyspnea and Inhalation Therapy Adherence among Patients with Bronchial Asthma

Associations between HIV infection status, psychosocial factors, and adjuvant endocrine therapy adherence among South African women with early-stage breast cancer.

We aimed to evaluate for associations between HIV status, psychosocial factors, and adjuvant endocrine therapy (AET) adherence in South African (SA) women with estrogen receptor positive (ER+) breast cancer (BC). We enrolled South African women with early-stage ER + BC in remission and prescribed tamoxifen or an aromatase inhibitor to the prospective observational study. We performed AET pill counts at enrollment, 12 weeks, and 24 weeks, and calculated adherence ratios of pills consumed between visits to days between visits. Women completed questionnaires on social support, attitude towards medication, health literacy, self-efficacy, mental health, and AET toxicity. We collected household wealth data. We used hierarchical linear (HLM) and structural equation modelling (SEM) to compare adherence ratios between women with and without HIV while adjusting for psychosocial factors. We collected adherence data from 239 women, 63 (26.4%) with co-morbid HIV. Comparing women with and without HIV, median AET adherence ratio was 0.88 vs 0.89, respectively (HLM p = 0.31). In our SEM model for the full cohort, mental health, healthcare savvy, and side effect burden latent variables were not significantly associated with adherence. In the subgroup of women living with HIV, lower SES quintile (β 0.04, SE 0.02, p = 0.08) and poorer mental health (β -0.02, SE 0.01, p = 0.10) showed trends toward association with adherence. HIV status is not predictive of AET adherence among SA women with ER + BC, though decreasing SES status and increasing mental health symptoms are marginally associated with adherence in women with BC and HIV.

Adherence to oral anticancer treatments: network and sentiment analysis exploring perceived internal and external determinants in patients with metastatic breast cancer

PurposeAdherence to oral anticancer treatments (OATs) is a critical issue in metastatic breast cancer (MBC) to enhance survivorship and quality of life. The study is aimed to analyze the main themes and attributes related to OATs in MBC patients. This research is part of a project titled “Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients" designed to produce a predictive model of non-adherence, a decision support system, and guidelines to improve adherence to OATs.MethodsThe study consists of an exploratory observational and qualitative analysis using a focus group method. A semi-structured interview guide was developed to handle relevant OAT themes. Wordcloud plots, network analysis, and sentiment analysis were performed.ResultsNineteen female MBC patients participated in the protocol (age mean 55.95, SD = 6.87). Four main themes emerged: (theme 1) individual clinical pathway; (theme 2) barriers to adherence; (theme 3) resources to adherence; (theme 4) patients’ perception of new technologies. The Wordcloud and network analysis highlighted the important role of treatment side effects and the relationship with the clinician in the modulation of adherence behavior. This result is consistent with the sentiment analysis underscoring patients experience fear of issues related to clinical values and ineffective communication and discontinuity of the doctor in charge of the patient care.ConclusionThe study highlighted the key role of the individual, relational variables, and side effects as internal and external determinants influencing adherence to MBC. Finally, the opportunity offered by eHealth technology to connect with other patients with similar conditions and share experiences could be a relief for MBC patients.

Adherence and Treat-to-Target Benchmarks in Older Adults With Gout Initiating Urate-Lowering Therapy in Ontario, Canada: A Population-Based Study.

We sought to evaluate urate-lowering therapy (ULT) adherence and treatment-to-target (T2T) serum uric acid (SUA) levels among older adults with gout starting ULT. We performed a population-based retrospective cohort study in Ontario, Canada in patients with gout aged ≥66 years newly dispensed ULT between 2010 and 2019. We defined successful T2T as patients having SUA levels <360 μmol/L (6 mg/dL) within 12 months after ULT dispensation. We also assessed adherence to ULT. Multilevel logistic regression clustered by ULT prescriber evaluated patient, physician, and prescription factors associated with reaching target SUA levels. Among 44,438 patients (mean ± SD age 76.0 ± 7.3 years; 64.4% male), 30,057 (67.6%) patients had ≥1 SUA test completed. Overall, 52.3% patients reached SUA target within 12 months, improving from 45.2% in 2010 to 61.2% in 2019 (P < 0.0001). ULT adherence was 55.3% overall and improved annually. Key factors associated with achieving T2T included febuxostat treatment (odds ratio [OR] 11.40, 95% confidence interval [95% CI] 5.10-25.43) (was only dispensed in 88 patients), ULT adherence (OR 5.17, 95% CI 4.89-5.47), allopurinol starting doses >50 mg (OR 2.53, 95% CI 2.14-2.99), colchicine/oral glucocorticoids co-prescription (OR 1.24, 95% CI 1.14-1.34), and ULT prescription from a rheumatologist. Only 52.3% of patients achieved an optimal SUA level within 1 year of ULT initiation. ULT adherence was suboptimal, although improving over time. ULT adherence and higher allopurinol starting doses had the strongest associations of achieving a target SUA level. This study highlights room for improvement in gout management and potential strategies to address care gaps.

National Implementation of CPAP Telemonitoring and a Pay-for-performance Scheme for Homecare Providers in France Leads to Prioritisation of Resources to Individuals with Low Therapy Adherence: The IMPACT-PAP Cohort Study

IntroductionLong-term adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea remains suboptimal and low adherence increases healthcare costs. This study investigated relationships between CPAP adherence and the intensity of support provided by homecare providers after implementation of telemonitoring and pay-for-performance reimbursement for CPAP in France. MethodsAdults who started CPAP in 2018/2019, used telemonitoring, and had ≥1 year of homecare provider data were eligible. The main objective was to determine associations between CPAP adherence at 1 month (low [<2h/night], intermediate [2 to <4h/night], high [≥4h/night]) and the number/type of homecare provider interactions (home visits, phone calls, mask change) during the first year. ResultsEleven thousand, one hundred sixty-six individuals were included (mean age 59.8±12.7 years, 67% male). The number of homecare provider interactions per person increased significantly as 1-month CPAP usage decreased (7.65±4.3, 6.5±4.0, 5.4±3.4 in low, intermediate and high adherence groups; p<0.01). There was marked improvement in device usage over the first 5–6 months of therapy in the low and intermediate adherence subgroups (p<0.05 after adjustment for age, sex, initial CPAP adherence, and number of interactions). After adjustment for age, sex and 1-month adherence, having 3–4 interactions was significantly associated with better 1-year adherence (odds ratio 1.24, 95% confidence interval 1.05–1.46), while having >7 interactions was significantly associated with worse 1-year adherence. ConclusionsThe telemonitoring/reimbursement scheme in France had a positive impact on CPAP adherence and facilitated a more personalised approach to therapy management, focusing resources on patients with low and intermediate adherence.

Effectiveness of a Multifaceted Mobile Health Intervention (Multi-Aid-Package) in Medication Adherence and Treatment Outcomes Among Patients With Hypertension in a Low- to Middle-Income Country: Randomized Controlled Trial.

The high prevalence of uncontrolled hypertension in Pakistan is predominantly attributed to poor medication adherence. As more than 137 million people in Pakistan use cell phones, a suitable mobile health (mHealth) intervention can be an effective tool to overcome poor medication adherence. We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country. A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group received standard care. The primary outcome was self-reported medication adherence measured using the Self-Efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill counting; the secondary outcome was systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication. Of 439 participants, 423 (96.4%) completed the study. At 6 months post intervention, the median SEAMS score was statistically significantly higher in the intervention group compared to the controls (median 32, IQR 11 vs median 21, IQR 6; U=10,490, P<.001). Within the intervention group, there was an increase in the median SEAMS score by 12.5 points between baseline and 6 months (median 19.5, IQR 5 vs median 32, IQR 11; P<.001). Results of the pill-counting method showed an increase in adherent patients in the intervention group compared to the controls (83/220, 37.2% vs 2/219, 0.9%; P<.001), as well as within the intervention group (difference of n=83, 37.2% of patients, baseline vs 6 months; P<.001). There was a statistically significant difference in the SBP of 7 mmHg between the intervention and control groups (P<.001) at 6 months, a 4 mmHg reduction (P<.001) within the intervention group, and a 3 mmHg increase (P=.314) within the controls. Overall, the number of patients with uncontrolled hypertension decreased by 46 in the intervention group (baseline vs 6 months), but the control group remained unchanged. The variables groups (adjusted odds ratio [AOR] 1.714, 95% CI 2.387-3.825), time (AOR 1.837, 95% CI 1.625-2.754), and age (AOR 1.618, 95% CI 0.225-1.699) significantly contributed (P<.001) to medication adherence. Multi-Aid-Package received a 94.8% acceptability score. The novel Multi-Aid-Package is an effective mHealth intervention for enhancing medication adherence and treatment outcomes among patients with hypertension in a low- to middle-income country. ClinicalTrials.gov NCT04577157; https://clinicaltrials.gov/study/NCT04577157.

A randomized controlled trial of an acceptance-based, insight-inducing medication adherence therapy (AIM-AT) for adults with early-stage psychosis

This study aimed to test the effectiveness of an acceptance-based medication adherence intervention for people with early-stage psychosis. An assessor-blind, three-arm randomized controlled trial design was used. One hundred and twenty-six participants who were adults with ≤3 years of psychosis were recruited from four district Integrated Community Centers for Mental Wellness in Hong Kong. They were randomly assigned to receive a 10-session acceptance-based, insight-inducing medication adherence therapy (AIM-AT) intervention, a conventional psychoeducation group program, or usual treatment (n = 42 per group). Primary outcomes were medication adherence and insight into the illness/treatment. All study outcomes were measured at recruitment and immediately, 6 months, and 12 months post-intervention. Participants in the AIM-AT experienced statistically significant improvements in the primary outcomes (levels of medication adherence and insight into illness/treatment), when compared to those in the other two groups over the 12-month follow-ups. The AIM-AT group also had significantly greater improvements in psychotic symptoms, psychosocial functioning, service satisfaction, length of rehospitalization, and total number of patients hospitalized over the follow-up period. These findings support the effectiveness of the AIM-AT to improve medication adherence, psychosocial health, and service satisfaction in people with early-stage psychosis.