Dataset Information

Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

ABSTRACT:

Background

Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM).

Methodology

A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence.

Results

At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18-0.53), p < 0.001)).

Conclusion

Psychological counseling and educational interventions, which were guided by HBM, significantly decreased treatment non-adherence level among intervention group. Provision of psychological counseling and health education to TB patients who are on regular treatment is recommended. This could be best achieved if these interventions are guided by behavioral theories and incorporated into the routine TB treatment strategy.

Trial registration

Pan African Clinical Trials Registry PACTR201506001175423.

SUBMITTER: Tola HH

PROVIDER: S-EPMC4864292 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

Tola Habteyes Hailu HH Shojaeizadeh Davoud D Tol Azar A Garmaroudi Gholamreza G Yekaninejad Mir Saeed MS Kebede Abebaw A Ejeta Luche Tadesse LT Kassa Desta D Klinkenberg Eveline E

PloS one 20160511 5

<h4>Background</h4>Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB ...[more]

PMID: 27167378

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Project description:Background The control of hypertension is low in low- and middle-income countries like India. We evaluated the effects of a nurse-facilitated educational intervention in improving the control rate of hypertension among school teachers in India. Methods and Results This was a cluster-randomized controlled trial involving 92 schools in Kerala, which were randomly assigned equally into a usual care group and an intervention group. Participants were 402 school teachers (mean age, 47 years; men, 29%) identified with hypertension. Participants in both study groups received a leaflet containing details of a healthy lifestyle and the importance of regular intake of antihypertensive medication. In addition, the intervention participants received a nurse-facilitated educational intervention on hypertension control for 3 months. The primary outcome was hypertension control. Key secondary outcomes included systolic blood pressure, diastolic blood pressure, and the proportion of participants taking antihypertensive medications. For the primary outcome, we used mixed-effects logistic regression models. Two months after a 3-month educational intervention, a greater proportion of intervention participants (49.0%) achieved hypertension control than the usual care participants (38.2%), with an odds ratio of 1.89 (95% CI, 1.06-3.35), after adjusting for baseline hypertension control. The odds of taking antihypertensive medications were 1.6 times higher in the intervention group compared with the usual care group (odds ratio, 1.62; 95% CI, 1.08-2.45). The reduction in mean systolic blood pressure was significantly greater in the intervention group by 4.2 mm Hg (95% CI, -7.2 to -1.1) than in the usual care group. Conclusions A nurse-facilitated educational intervention was effective in improving the control and treatment rates of hypertension as well as reducing systolic blood pressure among schoolteachers with hypertension. Registration URL: https://www.ctri.nic.in; Unique Identifier: CTRI/2018/01/011402.

Project description:BackgroundAs the burden of cardiovascular disease increases in sub-Saharan Africa, there is a growing need for low-cost interventions to mitigate its impact. Providing self-care health education to patients with chronic heart failure (CHF) is recommended as an intervention to prevent complications, improve quality of life, and reduce financial burdens on fragile health systems. However, little is known about health education's effectiveness at improving CHF self-management adherence in sub-Saharan Africa. Therefore the present study aimed to assess the effectiveness of an educational intervention to improve self-care adherence among patients with CHF at Debre Markos and Felege Hiwot Referral Hospitals in Northwest Ethiopia.MethodsTo address this gap, we adapted a health education intervention based on social cognitive theory comprising of intensive four-day training and, one-day follow-up sessions offered every four months. Patients also received illustrated educational leaflets. We then conducted a clustered randomized control trial of the intervention with 186 randomly-selected patients at Debre Markos and Felege Hiwot referral hospitals. We collected self-reported data on self-care behavior before each educational session. We analyzed these data using a generalized estimating equations model to identify health education's effect on a validated 8-item self-care adherence scale.ResultsSelf-care adherence scores were balanced at baseline. After the intervention, patients in the intervention group (n = 88) had higher adherence scores than those in the control group (n = 98). This difference was statistically significant (β = 4.15, p < 0.05) and increased with each round of education. Other factors significantly associated with adherence scores were being single (β = - 0.25, p < 0.05), taking aspirin (β = 0.76, p < 0.05), and having a history of hospitalization (β = 0.91, p < 0.05).ConclusionsWe find that self-care education significantly improved self-care adherence scores among CHF patients. This suggests that policymakers should consider incorporating self-care education into CHF management.Trial registration numberPACTR201908812642231.

Project description:BackgroundNurses are particularly vulnerable to acquiring tuberculosis (TB) because they are in the frontline of patient care. There is inadequate implementation of cost-effective TB infection control (TBIC) measures in most health facilities. Training has been shown to be effective in improving the knowledge and work practices of nurses. This study sought to utilize a multi-method educational intervention to improve the TBIC-related knowledge and practices of nurses in two secondary health facilities in Ibadan, South-West Nigeria.MethodsThis quasi-experimental study involved 200 nurses (100 each in the intervention and comparison groups). Baseline data were collected in May 2014. This was followed by training of the nurses in the intervention group. After 6?months, the second wave of data was collected and the nurses in the comparison group also received the training thereafter. The final wave of data collection took place 12?months after the commencement of the study. The mean scores of the nurses were determined and comparison was made between both groups at different time points using independent t-test.ResultsThe nurses in both groups were statistically comparable in their socio-demographic characteristics, and baseline mean knowledge (68.6 and 67.7%) and practice scores (79.1 and 80.6%) respectively. After the intervention group received the intervention, there were appreciable improvements in the scores at 6?months (knowledge - 85.9%, practice - 98.5%), which were significantly different from those of the comparison group (knowledge - 69.5%, practice - 78.8%). A large effect size was demonstrated in the improvement in knowledge score in the intervention group at 6?months compared with the other group (Cohen's d?=?1.7). Similarly, there were improvements in the scores of the nurses in the comparison group at 12?months after the group had also received the intervention (knowledge - 88.2%, practice - 93.5%). At this point, the mean scores between both groups were no longer significantly different.ConclusionsThe improvement in post-intervention scores implies that the educational intervention adopted for this study was effective in improving TBIC among the nurses. It also underscores the importance of continuous training/retraining of nurses and other healthcare workers in improving and sustaining TBIC at health facilities.

Project description:BACKGROUND:Adolescent pregnancy is a worldwide problem because of its health, social, economic and political repercussions on the globe. Even though the rates of adolescent pregnancy have declined over the decade, there is still unacceptably high rates especially in lower and middle-income countries including Ghana. Although the problem has been widely investigated, there is little information on the effectiveness of different methods to improve adolescent sexual abstinence based on theoretical models. This study is aimed to assess an educational intervention program on sexual abstinence based on the Health Belief Model (HBM) among adolescent girls in Northern Ghana. METHODS:A cluster randomized control trial was conducted in Ghana from April to August 2018. Participants within the ages of 13-19?years were enrolled voluntarily from six randomly selected Senior High Schools (3 for intervention and 3 for control). A total of 363 adolescent were enrolled. A self-structured questionnaire was administered to both groups of participants at baseline and endpoint of the study. Control participants received their normal classes whiles the intervention group additionally received comprehensive sexuality education for 1 month. Qualified midwives conducted the health education program. At least two sessions were conducted for each participating class weekly. The lessons focused on perceived susceptibility, perceived severity of adolescent pregnancy, perceived benefits, perceived barriers to adolescent pregnancy prevention, personal and family values, perceived self-efficacy and knowledge of contraceptives. Educational strategies such as discussions, demonstrations, role-play and problem solving techniques were used to deliver the lessons. Sexual abstinence was the outcome variable of the study and it was measured after 3 months of the intervention. Binary logistic regression was used to assess the impact of the intervention on sexual abstinence practice. RESULTS:At baseline, there was no difference between control and intervention groups. The mean score of Knowledge and attitude for control were (58.17 and 139.42) and intervention (60.49 and 141.36) respectively. Abstinence practice was 69.4% for control and 71.6% in the intervention group. However, after the intervention, the mean score of knowledge and attitude for control were (87.58 and 194.12) respectively. Sexual abstinence in the control was 84.4% and intervention was 97.3% respectively. The educational interventions resulted in a significant difference in sexual abstinence between intervention and control groups (OR?=?13.89, 95% Confidence Interval (2.46-78.18, P?<?0.003). CONCLUSION:Educational intervention, which was guided by HBM, significantly improved sexual abstinence and the knowledge of adolescents on pregnancy prevention among the intervention group. Provision of comprehensive sex education guided by behavioural theories to adolescents at Senior High Schools in Ghana is recommended. TRIAL REGISTRATION:This trial was retrospectively registered in Protocol Registration and Results System (PRS) with trial number NCT03384251 .

Project description:Mobile text messaging and medication monitors (medication monitor boxes) have the potential to improve adherence to tuberculosis (TB) treatment and reduce the need for directly observed treatment (DOT), but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control). Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined) withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients) or were switched to a different treatment model because of hospitalisation or travel (58 patients), leaving 4,173 TB patients (by arm: 1,104 control, 1,008 text messaging, 997 medication monitor, 1,064 combined). The cluster geometric mean of the percentage of patient-months on TB treatment where at least 20% of doses were missed was 29.9% in the control arm; in comparison, this percentage was 27.3% in the text messaging arm (adjusted mean ratio [aMR] 0.94, 95% CI 0.71, 1.24), 17.0% in the medication monitor arm (aMR 0.58, 95% CI 0.42, 0.79), and 13.9% in the combined arm (aMR 0.49, 95% CI 0.27, 0.88). Patient loss to follow-up was lower in the text messaging arm than the control arm (aMR 0.42, 95% CI 0.18-0.98). Equipment malfunction or operation error was reported in all study arms. Analyses separating patients with and without medication monitor problems did not change the results. Initiation of intensive management was underutilised.This study is the first to our knowledge to utilise a randomised trial design to demonstrate the effectiveness of a medication monitor to improve medication adherence in TB patients. Reminders from medication monitors improved medication adherence in TB patients, but text messaging reminders did not. In a setting such as China where universal use of DOT is not feasible, innovative approaches to support patients in adhering to TB treatment, such as this, are needed.Current Controlled Trials, ISRCTN46846388.

Project description:Summary Background Drug-sensitive tuberculosis treatment requires 6 months of therapy, so adherence problems are common. Digital adherence technologies might improve tuberculosis treatment outcomes. We aimed to evaluate the effect of a daily reminder medication monitor, monthly review of adherence data by the health-care provider, and differentiated care for patients with adherence issues, on tuberculosis treatment adherence and outcomes. Methods We did a cluster-randomised superiority trial across four prefectures in China. 24 counties or districts (clusters) were randomly assigned (1:1) to intervention or control groups. We enrolled patients aged 18 years or older with GeneXpert-positive, rifampicin-sensitive pulmonary tuberculosis, who were receiving daily fixed-dose combination treatment. Patients in the intervention group received a medication monitor for daily drug-dosing reminders, monthly review of adherence data by health-care provider, and management of poor adherence; and patients in the control group received routine care (silent-mode monitor-measured adherence). Only the independent endpoints review committee who assessed endpoint data for some participants were masked to study group assignment. Patients were followed up (with sputum solid culture) at 12 and 18 months. The primary outcome was a composite of death, loss to follow-up, treatment failure, switch to multidrug-resistant tuberculosis treatment, or tuberculosis recurrence by 18 months from treatment start, analysed in the intention-to-treat population. Analysis accounted for study design with multiple imputation for the primary outcome. This trial is now complete and is registered with ISRCTN, 35812455. Findings Between Jan 26, 2017, and April 3, 2019, 15 257 patients were assessed for eligibility and 3074 were enrolled, 2686 (87%) of whom were included in the intention-to-treat population. 1909 (71%) of 2686 patients were male, 777 (29%) were female, and the median age was 44 years (IQR 29–58). By 18 months from treatment start, using multiple imputation for missing outcomes, 239 (16% [geometric mean of cluster-level proportion]) of 1388 patients in the control group and 224 (16%) of 1298 in the intervention group had a primary composite outcome event (289 [62%] of 463 events were loss to follow-up during treatment and 42 [9%] were tuberculosis recurrence). The intervention had no effect on risk of the primary composite outcome (adjusted risk ratio 1·01, 95% CI 0·73–1·40). Interpretation Our digital medication monitor intervention had no effect on unfavourable outcomes, which included loss to follow-up during treatment, tuberculosis recurrence, death, and treatment failure. There was a failure to change patient management following identification of treatment non-adherence at monthly reviews. A better understanding of adherence patterns and how they relate to poor outcomes, coupled with a more timely review of adherence data and improved implementation of differentiated care, may be required. Funding Bill & Melinda Gates Foundation.

Project description:BackgroundDigital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited. We aim to implement and evaluate the effectiveness of smart pillboxes and medication labels linked to an adherence data platform, to create a differentiated care response to patient adherence and improve TB care among adult pulmonary TB participants. Our study is part of the Adherence Support Coalition to End TB (ASCENT) project in Ethiopia.Methods/designWe will conduct a pragmatic three-arm cluster-randomised trial with 78 health facilities in two regions in Ethiopia. Facilities are randomised (1:1:1) to either of the two intervention arms or standard of care. Adults aged ≥ 18 years with drug-sensitive (DS) pulmonary TB are enrolled over 12 months and followed-up for 12 months after treatment initiation. Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses. Participants at standard of care facilities receive routine care. For those that had bacteriologically confirmed TB at treatment initiation and can produce sputum without induction, sputum culture will be performed approximately 6 months after the end of treatment to measure disease recurrence. The primary endpoint is a composite unfavourable outcome measured over 12 months from TB treatment initiation defined as either poor end of treatment outcome (lost to follow-up, death, or treatment failure) or treatment recurrence measured 6 months after the scheduled end of treatment. This study will also evaluate the effectiveness, feasibility, and cost-effectiveness of DAT systems for DS-TB patients.DiscussionThis trial will evaluate the impact and contextual factors of medication label and smart pillbox with a differentiated response to patient care, among adult pulmonary DS-TB participants in Ethiopia. If successful, this evaluation will generate valuable evidence via a shared evaluation framework for optimal use and scale-up.Trial registrationPan African Clinical Trials Registry PACTR202008776694999, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 , registered on August 11, 2020.

Project description:BackgroundTuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality rate by 95%, TB incidence rate by 90%, and catastrophic costs due to TB by 2035, compared with a 2015 level. To achieve these ambitious targets, several interventions have been implemented in the last few years, resulting in major progress toward reducing the burden of TB. However, over one-third of the global TB cases remained undetected and never received treatment. Most of those undetected cases were found in low- and middle-income countries such as Ethiopia. Though several interventions were implemented to increase TB case detection and mitigate catastrophic costs associated with TB, sustaining these interventions in resource-constrained settings remains challenging. Consequently, an alternative method is needed to increase TB case detection while decreasing diagnosis delays and catastrophic costs. Therefore, this study aimed to integrate traditional TB care into modern TB care to improve TB control programs, including early TB case detection, and reduce catastrophic costs in high TB burden settings such as Ethiopia.MethodsA cluster randomized controlled trial will be conducted in northwest Ethiopia to determine the effectiveness of integrating traditional care with modern TB care. The intervention will be conducted in randomly selected districts in the South Gondar Zone. The control group will be an equal number of districts with usual care. The intervention comprised three key components, which include referral linkage from traditional to modern health care; training of health professionals and traditional care providers in three different rounds to increase their knowledge, attitude, and skills toward the referral systems; and TB screening at traditional health care sites. The primary outcomes of interest will be an increase in case detection rate, and the secondary outcomes of interest will be decreased diagnosis delays and catastrophic costs for TB patients. Data will be collected in both the intervention and control groups on the main outcome of interest and a wide range of independent variables. Generalized linear mixed models will be used to compare the outcome of interest between the trial arms, with adjustment for baseline differences.DiscussionThis cluster-randomized controlled trial study will assess the effectiveness of a strategy that integrates traditional healthcare into the modern healthcare system for the control and prevention of TB in northwest Ethiopia, where nearly 90% of the population seeks care from traditional care systems. This trial will provide information on the effectiveness of traditional and modern healthcare integration to improve TB case detection, early diagnosis, and treatment, as well as reduce the catastrophic costs of TB.Trial registrationClinicalTrials.gov NCT05236452. Registered on July 22, 2022.

Project description:BackgroundEarly diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead. However, dementia remains underdetected and suboptimally managed in general practice. Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia.MethodsThe tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design, with two arms: usual/normal care control versus educational intervention. The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year. Case identification was a secondary outcome measure.Results23 practices in South-East England participated. A total of 1,072 patients with dementia (intervention: 512, control: 560) had information in their medical records showing the number of reviews within 12 months (or a proportion of) before intervention or randomization and within 12 months (or a proportion of) after. The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 (SD 1.09; minimum 0; median 1; maximum 8) compared with 0.89 (SD 0.92; minimum 0; median 1; maximum 4) before intervention. In the control group prior to randomization the mean total number of dementia management reviews was 1.66 (SD 1.87; minimum 0; median 1; maximum 12) and in the period after randomization it was 1.56 (SD 1.79; minimum 0; median 1; maximum 11). Case detection rates were unaffected. The estimated incidence rate ratio for intervention versus control group was 1.03 (P = 0.927, 95% CI 0.57 to 1.86).ConclusionsThe trial was timely, coinciding with financial incentives for dementia management in general practice (through the Quality Outcomes Framework); legal imperatives (in the form of the Mental Capacity Act 2005); policy pressure (The National Dementia Strategy 2009); and new resources (such as dementia advisors) that increased the salience of dementia for general practitioners. Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices, nor did it increase case identification.Trial registrationNCT00866099/Clinical Trials.

Dataset Information

Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

Background

Methodology

Results

Conclusion

Trial registration

Publications

Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

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