Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

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Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147510 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7510

Author(s):

Guillermo García Pérez de Sevilla ◽

Olga Barceló Guido ◽

María de la Paz De la Cruz ◽

Ascensión Blanco Fernández ◽

Lidia B. Alejo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Effect Size ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Nutrition Intervention ◽

Sitting Time ◽

Post Intervention ◽

University Employees ◽

Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

European Journal of Ophthalmology ◽

10.1177/11206721211018365 ◽

2021 ◽

pp. 112067212110183

Author(s):

Evelyn Tran ◽

Carina Sanvicente ◽

Lisa A Hark ◽

Jonathan S Myers ◽

Qiang Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Educational Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Selective Laser Trabeculoplasty ◽

First Line ◽

Randomized Controlled ◽

Laser Trabeculoplasty ◽

Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

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Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

10.2196/preprints.36480 ◽

2022 ◽

Author(s):

Maryam Zahid ◽

Ume Sughra

Keyword(s):

Nutritional Status ◽

Usual Care ◽

Usual Care Group ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

Randomized Controlled ◽

Nutritional Status Of Children ◽

Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

10.21203/rs.3.rs-265906/v2 ◽

2021 ◽

Author(s):

Remi Yoshikata ◽

Khin Zay Yar Myint ◽

Hiroaki Ohta ◽

Yoko Ishigaki

Keyword(s):

Randomized Controlled Trial ◽

Visceral Fat ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Climacteric Symptoms ◽

Post Intervention ◽

Randomized Controlled ◽

Menopausal Women ◽

Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

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App-based supplemental exercise in rehabilitation, adherence, and effect on outcomes: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520928119 ◽

2020 ◽

Vol 34 (8) ◽

pp. 1083-1093

Author(s):

Ingrid Li ◽

Tram Bui ◽

Hoang T Phan ◽

Ana Llado ◽

Clayton King ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Length Of Stay ◽

Usual Care ◽

Outcome Measures ◽

Walking Speed ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Walk Test ◽

Randomized Controlled

Question: To determine the uptake of an app-based supplemental exercise programme in a rehabilitation setting and the effect of such a programme on length of stay and function compared to usual care physiotherapy. Design: Randomized controlled trial with random allocation and assessor blinding. Participants: A total of 144 individuals with mixed diagnoses (orthopaedic, neurological, reconditioning) admitted for inpatient sub-acute rehabilitation. Interventions: Participants were randomly allocated to usual care physiotherapy (control group) or usual care physiotherapy with the addition of an app-based supplemental exercise programme (intervention group). Outcome measures: The primary measure of interest was total supplementary exercise dosage completed by the intervention group. The primary between-group outcome measure was length of stay with secondary measures including walking endurance (Six-Minute Walk Test), walking speed (10-Metre Walk Test), functional mobility (Timed Up and Go Test) and level of disability (Functional Independence Measure). Results: Participants in the intervention group performed 7 minutes (SD: 9) or 49 repetitions (SD: 48) of supplementary exercise using the app each day. There were no differences between the groups for length of stay (mean difference (MD): −0.5 days, 95% confidence interval (CI): −3.2 to 2.2) or change in any secondary functional outcome measures, including walking speed (MD: −0.1 m/s, 95% CI: −0.2 to 0.0) and disability (MD: −0.9, 95% CI: −3.6 to 1.8). Conclusion: A small supplementary exercise dose was achieved by participants in the intervention group. However, such a programme did not affect length of stay or functional outcomes when compared to usual care.

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Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

Palliative & Supportive Care ◽

10.1017/s1478951518000901 ◽

2019 ◽

Vol 17 (1) ◽

pp. 46-53

Author(s):

Kaori Ichihara ◽

Sayako Ouchi ◽

Sachiko Okayama ◽

Fukiko Kinoshita ◽

Mitsunori Miyashita ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Usual Care ◽

Pain Assessment ◽

Spiritual Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

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A randomized controlled trial of a brief educational and psychological intervention for patients presenting to a cardiac clinic with palpitation

Psychological Medicine ◽

10.1017/s0033291702005536 ◽

2002 ◽

Vol 32 (4) ◽

pp. 699-706 ◽

Cited By ~ 11

Author(s):

R. MAYOU ◽

D. SPRIGINGS ◽

J. BIRKHEAD ◽

J. PRICE

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Educational Intervention ◽

Psychological Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Treatment Needs ◽

Randomized Controlled

Background. We sought to determine whether a brief psycho-educational intervention reduced disability in patients with benign palpitation.Method. In a pragmatic randomized controlled trial within a cardiology clinic at a district general hospital, 80 consecutive patients diagnosed as having benign palpitation – either palpitation due to awareness of extrasystoles or sinus rhythm – with associated distress or disability were randomized to an intervention group (usual care plus nurse-delivered intervention based on cognitive-behavioural principles) or to a control group (usual care). Principal outcome was difference in proportion of participants with good or excellent researcher-rated activity levels at 3 months. Subsidiary outcomes were self-rated symptoms, distress and disability, researcher-rated unmet treatment needs.Results. The principal outcome showed a statistically and clinically significant benefit for the intervention group, with a number needed to treat of 3 (95% CIs 2 to 7). All but one subsidiary outcomes also showed a difference in favour of the intervention group, and several differences reached statistical significance. Significantly more of the control group had unmet treatment needs at 3 months.Conclusions. A brief, nurse-delivered, psycho-educational intervention, was an effective treatment for benign palpitation. Further evaluation, including assessment of cost-effectiveness, is needed. The findings have application to the care of patients presenting with other types of ‘unexplained’ medical symptoms.

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Screening and patient-tailored care for emotional and cognitive problems compared to care as usual in patients discharged home after ischemic stroke (ECO-stroke): a protocol for a multicenter, patient-blinded, cluster randomized controlled trial

BMC Health Services Research ◽

10.1186/s12913-020-05902-2 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

J. P. L. Slenders ◽

R. M. Van den Berg-Vos ◽

C. M. van Heugten ◽

J. M. A. Visser-Meily ◽

S. M. A. A. Evers ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Ischemic Stroke ◽

Cost Effectiveness ◽

Usual Care ◽

Controlled Trial ◽

Intervention Group ◽

Emotional Problems ◽

Clinical Effectiveness ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke. Methods / design A multicenter, patient-blinded, cluster randomized controlled trial will be performed. Centers will be randomized (1:1) to the intervention group or the usual care group. Patients (> 18 years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included. In the intervention group, patients will receive a short, individualized, semi-structured consultation by specialized nurses in addition to usual care. This consultation includes 1) screening for cognitive and emotional problems, 2) screening for restrictions in participation, 3) promotion of self-management strategies and 4) a decision tool for referral to rehabilitation services. The intervention will be performed approximately 6 weeks after the stroke at the neurology outpatient clinics and will take approximately 60 min. The control group will receive care as usual. Both groups will be followed-up at 6 weeks, 3 months and 12 months after stroke. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months. A cost-effectiveness analysis and process evaluation will be performed alongside. Discussion This trial is the first to evaluate clinical effectiveness, cost-effectiveness and implementation of screening and patient-tailored care for cognitive and emotional problems compared to care as usual in patients discharged home after ischemic stroke. Potentially, this will improve the outcomes for patients with frequently occurring cognitive and emotional problems after stroke. Trial registration Netherlands Trial Register: NL7295, registered 25 September 2018

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The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

International Journal of Social Psychiatry ◽

10.1177/0020764017693652 ◽

2017 ◽

Vol 63 (3) ◽

pp. 212-223 ◽

Cited By ~ 7

Author(s):

Abdalhadi Hasan ◽

Mahmoud Musleh

Keyword(s):

Randomized Controlled Trial ◽

Psychiatric Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Post Intervention ◽

Treatment As Usual ◽

Randomized Controlled ◽

Secondary Outcomes ◽

The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

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Effectiveness of Mobile Phone-Based Support on Exclusive Breastfeeding and Infant Growth in Nigeria: A Randomized Controlled Trial

Journal of Tropical Pediatrics ◽

10.1093/tropej/fmaa076 ◽

2020 ◽

Author(s):

Daprim S Ogaji ◽

Adaku O Arthur ◽

Innocent George

Keyword(s):

Randomized Controlled Trial ◽

Mobile Phone ◽

Usual Care ◽

Exclusive Breastfeeding ◽

Controlled Trial ◽

Intervention Group ◽

Control Groups ◽

Randomized Controlled ◽

The Difference ◽

And Control

Abstract Background This study examined whether mobile phone-based support improve the rates, duration of exclusive breastfeeding (EBF) as well as infant growth patterns in Nigeria. Methods A 6-month prospective randomized controlled trial with 75 participants assigned to receive ‘usual care’ or ‘mobile phone-based support in addition to usual care’ EBF rates and duration as well as anthropometric measurements of infants before and after intervention were compared using proportions and mean differences. Results Attrition rates of 10.7% and 14.7% were observed in the intervention and control groups, respectively. Treatment groups were identical in all baseline characteristics and participants in the intervention group showed a slower rate of decline in the practice of EBF. The mean difference of 0.6 months (95% confidence interval: −0.22, 1.42) in EBF duration between intervention and control groups was not statistically significant (t = 1.45; p = 0.149). Similarly, the difference in the EBF rates at the 6th month for the intervention (55.2%) and control (46.8%) groups was not statistically significant (χ2 = 0.623; p = 0.430). Although the intervention group had significantly higher mean weight (p = 0.030) and length (p = 0.044) at the 6th month, the difference in the gain in weight and length of these infants over the period was only significant for the weight (p = 0.044). Although the incidence of adverse clinical nutritional status was more in the control group, these differences were not statistically significant. Conclusion Mobile phone-based intervention has positive effects on the rate and duration of EBF as well as the growth of young infants. Sustaining this simple and cheap technology will improve infant wellbeing especially in resource-constrained settings.

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