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result(s) for
"Treatment Adherence"
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A health promotion model-based intervention to enhance treatment adherence in patients with type 2 diabetes
2024
Background
The present study aimed to determine the effect of an intervention based on Pender’s health promotion model (HPM) on treatment adherence in patients with type 2 diabetes (T2D).
Methods
The present quasi-experimental study with a 3-month follow-up was conducted in Bandar Abbas, a city in the south of Iran in 2023. The intervention group (IG) with a total number of 95 T2D patients was selected from Hormuz diabetes clinic and the control group (CG) with 95 T2D patients was selected from comprehensive health centers through a clustering sampling method. The educational intervention was implemented in 10 sessions to improve patients’ treatment adherence. The teaching methods in training sessions were lectures, joint discussions, Q&A, role-play and peer training. The participants were evaluated using a researcher-made questionnaire including the constructs of Pender’s HPM about T2D treatment adherence, hemoglobin A1C (HbA1C), and BMI. Independent-samples t-test, paired-samples t-test, covariance analysis and stepwise regression analysis were used. Data analysis was done in SPSS 26.
Findings
Three months after the intervention, in comparison to the CG, the mean and standard deviation of treatment adherence benefits (
p
= 0.002), treatment adherence self-efficacy (
p
= 0.010), treatment adherence related affect (
p
= 0.001), interpersonal influences (
p
= 0.012), commitment to plan of action (
p
< 0.001), treatment adherence behavior (
p
= 0.022), treatment adherence experiences (
p
= 0.001) was higher in the IG. The mean and standard deviation of situational influences (
p
< 0.001), immediate competing demands and preferences (
p
= 0.018) were lower than the CG. The results obtained from the analysis of covariance proved the effectiveness of the intervention in the constructs of Pender’s HPM and HbA1C in participants of the IG (
p
< 0.001). The regression analysis showed, after the intervention, for every 1 unit of change in commitment to behavior planning, action related affect and perceived self-efficacy, compared to before the intervention, there were 0.22 units, 0.16 units and 0.26 units of change in the behavior score in the IG.
Conclusion
The findings proved the effectiveness of the educational intervention in improving the constructs in Pender’s HPM and the blood sugar level of T2D patients. As the results of the educational intervention showed, the use of a suitable educational approach as well as the development of appropriate educational content for the target population can significantly improve the treatment adherence behavior.
Trial registration
This study is registered on the Iranian Registry of Clinical Trials (IRCT20211228053558N1:
https://www.irct.ir/trial/61741
) and first release date of 17th March 2022.
Journal Article
Effectiveness of an mHealth Intervention With Short Text Messages to Promote Treatment Adherence Among HIV-Positive Mexican Adults: Randomized Controlled Trial
by
Herrera Godina, Melva Guadalupe
,
Martínez Ayala, Pedro
,
Del Moral Trinidad, Luis Eduardo
in
Adult
,
Adults
,
Antiretroviral drugs
2025
HIV continues to be a public health concern in Mexico and Latin America due to an increase in new infections, despite a decrease being observed globally. Treatment adherence is a pillar for achieving viral suppression. It prevents the spread of the disease at a community level and improves the quality and survival of people living with HIV. Thus, it is important to implement strategies to achieve sustained treatment adherence.
The objective of this study is to evaluate the effectiveness of a mobile health (mHealth) intervention based on SMS text messages to increase antiretroviral therapy (ART) adherence for HIV-positive adults.
A randomized controlled trial was performed at the Hospital Civil de Guadalajara - Fray Antonio Alcalde on HIV-positive adults who had initiated ART. The mHealth intervention included the use of SMS text messages as a reminder system for upcoming medical examinations and ART resupply to increase adherence. This intervention was provided to 40 participants for a 6-month period. A control group (n=40) received medical attention by the standard protocol used in the hospital. Intervention effectiveness was assessed by quantifying CD4+ T cells and viral load, as well as a self-report of adherence by the patient.
The intervention group had greater adherence to ART than the control group (96% vs 92%; P<.001). In addition, the intervention group had better clinical characteristics, including a lower viral load (141 copies/mL vs 2413 copies/mL; P<.001) and a trend toward higher CD4+ T cells counts (399 cells/μL vs 290 cells/μL; P=.15).
These results show that an mHealth intervention significantly improves ART adherence. Implementing mHealth programs could enhance the commitment of HIV-positive adults to their treatment.
Journal Article
Group Prenatal Care Attendance and Women’s Characteristics Associated with Low Attendance: Results from Centering and Racial Disparities (CRADLE Study)
by
Chen, Liwei
,
Crockett, Amy
,
Francis, Ellen
in
Childrens health
,
Gynecology
,
Low income groups
2019
ObjectivesGroup prenatal care (GPC), an alternative to individual prenatal care (IPC), is becoming more prevalent. This study aimed to describe the attendance and reasons of low attendance among pregnant women who were randomly assigned to receive GPC or IPC and explore the maternal characteristics associated with low-attendance.MethodsThis study was a descriptive study among Medically low risk pregnant women (N = 992) who were enrolled in an ongoing prospective study. Women were randomly assigned to receive CenteringPregnany GPC (N = 498) or IPC (N = 994) in a single clinical site The attendance frequency and reason for low-attendance (i.e. ≤ 5/10 sessions in GPC or ≤ 5 visits in IPC) were described separately in GPC and IPC. Multivariable logistic regressions were performed to explore the associations between maternal characteristics and low-attendance.ResultsOn average, women in GPC attended 5.32 (3.50) sessions, with only 6.67% attending all 10 sessions. Low-attendance rate was 34.25% in GPC and 10.09% in IPC. The primary reasons for low-attendance were scheduling barriers (23.19%) and not liking GPC (16.43%) in GPC but leaving the practice (34.04%) in IPC. In multivariable analysis, lower perceived family support (P = 0.01) was positively associated with low-attendance in GPC, while smoking in early pregnancy was negatively associated low-attendance (P = 0.02) in IPC.Conclusions for PracticeScheduling challenges and preference for non-group settings were the top reasons for low-attendance in GPC. Changes may need to be made to the current GPC model in order to add flexibility to accommodate women’s schedules and ensure adequate participation.Trial registrationNCT02640638 Date Registered: 12/20/2015.
Journal Article
Role of habit in treatment adherence among adults with cystic fibrosis
2019
Among adults with cystic fibrosis (CF), medication adherence is low and reasons for low adherence are poorly understood. Our previous exploratory study showed that stronger ‘habit’ (ie, automatically experiencing an urge to use a nebuliser) was associated with higher nebuliser adherence. We performed a secondary analysis of pilot trial data (n=61) to replicate the earlier study and determine whether habit–adherence association exists in other cohorts of adults with CF. In this study, high adherers also reported stronger habit compared with low adherers. Habit may be a promising target for self-management interventions.Trial registration numberACtiF pilot, ISRCTN13076797.
Journal Article
The effect of life skills training on reducing domestic violence and improving treatment adherence in women with diabetes experiencing intimate partner violence: a randomized clinical trial based on the theory of self-efficacy
2024
Background
Intimate partner violence (IPV) is a global health problem and the cause of chronic diseases, such as diabetes. It has a negative effect on adherence to treatment, decreases self-efficacy beliefs, and intensifies stress in women. Therefore, this study aimed to investigate the effect of life skills training based on the self-efficacy theory on IPV and adherence to treatment in women with type 2 diabetes.
Methods
This trial was conducted using a pretest-posttest design and follow-up after one month. The samples included 100 women selected by convenience sampling with random block allocation with type 2 diabetes and IPV. The intervention consisted of 8 sessions over one month of life skills training based on self-efficacy theory. Participants completed questionnaires at pre-test, post-test and follow-up, including a demographic information form and questionnaires on IPV and treatment adherence. Considered statistically significant at
P
< 0. 05.
Results
The mean changes in IPV scores from the pre-test to the post-test were − 8.38 ± 4.06 and − 0.06 ± 3.09 in the intervention and control groups, respectively. Also, the reduction in the intervention group was significantly more than in the control group (
P
< 0.001; 95%CI=-9.75; -6.89). The mean changes in IPV scores from post-test to follow-up were − 1.36 ± 3.47 and 1.50 ± 4.14 in intervention and control groups, respectively, indicating a statistically significant difference between the two groups (
P
< 0.001; 95%CI=-4.38; -1.34). The mean changes in adherence scores from the pre-test to the post-test were 11.40 ± 4.23 and 0.68 ± 3.49 in the intervention and control groups, respectively. The increase was significantly higher in the intervention group than in the control group (
P
< 0.001; 95%CI = 9.18; 12.26). The mean changes in adherence scores from post-test to follow-up were 2.68 ± 5.06 and − 0.86 ± 2.43 in the intervention and control groups, respectively. The difference between the two groups was statistically significant (
P
< 0.001; 95%CI = 1.95; 5.12).
Conclusion
Life skills training based on self-efficacy theory reduced IPV and improved treatment compliance in women with diabetes under IPV. It is recommended that this training be taught to other patients with chronic conditions as a means of violence prevention and treatment adherence.
Trial registration
The trial was registered with the Iranian Registry of Clinical Trials (IRCT) on 13 October 2022 and can be found on the Iranian Registry of Clinical Trials platform. IRCT registration number: IRCT20090522001930N6.
Journal Article
Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence
by
Rosencovich, Nicolas
,
Waitman, Cristian
,
Ceberio, Marcelo Rodriguez
in
Abstinence
,
Adherence
,
Adult
2020
Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation.
This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness.
A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit.
Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ
=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program.
Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes.
ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181.
Journal Article
Effect of Therapy Reminder Application on Treatment Adherence in Adults with Beta-Thalassemia Major: A Randomized Clinical Trial
by
Arian, Mahdieh
,
Mehrabadi, Fatemeh
,
Badiee, Zahra
in
Adult
,
beta-Thalassemia - drug therapy
,
beta-Thalassemia - psychology
2025
Non-adherence to treatment in patients with beta-thalassemia major (BTM) presents a significant challenge in effective disease management. This study aimed to assess the effect of a therapy reminder application (app) on treatment adherence in adult patients with BTM in Mashhad in 2024.
A randomized clinical trial was conducted in 2024 at a thalassemia clinic affiliated with Mashhad University of Medical Sciences (Mashhad, Iran). Participants were randomly assigned to the intervention and control groups, using permuted block randomization, with concealed allocation. The intervention group used the ThalaMe therapy reminder app for 8 weeks (February-July 2024), while the control group received standard care. Medication adherence was measured using the Morisky Medication Adherence Scale (MMAS-8) and the Chronic Disease Treatment Adherence Questionnaire (CDTAQ) before and after the intervention. Statistical analysis was conducted using SPSS software, using paired
tests or Wilcoxon signed-rank tests for within-group comparisons and independent
tests or Mann-Whitney U tests for between-group comparisons. P<0.05 was considered statistically significant.
The study included 76 adult patients with BTM, equally distributed between the intervention and control groups (n=38 each). Baseline measurements showed no significant differences between groups in either MMAS-8 scores (P=0.75) or CDTAQ scores (P=0.11). The MMAS-8 was inversely scored, with lower scores indicating higher adherence. Following the 8-week intervention period, the group using the ThalaMe app demonstrated significantly better adherence outcomes (1.05±0.78) than the controls (2.92±1.4, P<0.001). The intervention group had significantly higher CDTAQ scores (185.5±8.07) than the control group (151.79±27.08, P<0.001).
The therapy reminder app significantly enhanced medication adherence and treatment management in patients with BTM, while simultaneously enhancing patient and family engagement through counseling.
IRCT20240222061079N1.
Journal Article
Effectiveness of a Mobile Health Intervention (DOT Selfie) in Increasing Treatment Adherence Monitoring and Support for Patients With Tuberculosis in Uganda: Randomized Controlled Trial
2025
Directly observed therapy (DOT) is the standard method for monitoring adherence to tuberculosis (TB) treatment. However, implementing DOT poses challenges for both patients and providers due to limited financial and human resources. Increasing evidence suggests that emerging digital adherence technologies, such as video directly observed therapy (VDOT), can serve as viable alternatives.
This study aims to evaluate the effectiveness of VDOT compared with usual care directly observed therapy (UCDOT).
Between July 2020 and October 2021, we conducted a 2-arm, parallel-group, open-label randomized trial with a 1:1 assignment to receive either the VDOT intervention (n=72) or UCDOT (n=72) for treatment adherence monitoring at public health clinics in Kampala, Uganda. Each group was further stratified to ensure equal numbers of males and females. Eligible patients were aged 18-65 years, had a confirmed diagnosis of TB, and were undergoing daily treatment. The VDOT group was provided with a smartphone equipped with an app, while the UCDOT group followed the routine monitoring practices outlined by the Uganda National TB Program. We tested the hypothesis that VDOT was more effective than UCDOT for monitoring medication adherence. The primary outcome was adherence, defined as having ≥80% of the expected doses observed during the 6-month treatment period. An intention-to-treat analysis was conducted, and multivariable logistic regression was used to estimate the effect of the intervention on adherence monitoring. Adjusted relative risk ratios and their corresponding 95% CIs are presented. Secondary outcomes included treatment completion, loss to follow-up, death, and reasons for missed videos in the intervention group.
The intention-to-treat analysis included 142 participants, with 2 excluded due to discontinuation of medication within the first week after enrollment. The median age of participants was 34 (IQR 26-45) years. The median fraction of expected doses observed (FEDO) was significantly higher in the VDOT group compared with the UCDOT group (100, IQR 80-100 vs 30, IQR 10-60, respectively; P<.001). When using a FEDO cutoff of ≥80% to define optimal adherence, 63 of 142 (44%) patients met the threshold, with a significant difference between the VDOT and UCDOT groups (56/71, 79% vs 7/71, 10%, P<.001). After adjusting for confounders, VDOT users were significantly more likely to achieve ≥80% of their expected doses observed compared with UCDOT users (adjusted risk ratio 8.4, 95% CI 4.16-17.0). The most common reasons for failing to submit videos of medication intake were an uncharged phone battery, forgetting to record videos during medication intake, and losing the smartphone.
Enhanced VDOT was more effective than UCDOT in increasing adherence monitoring among patients with TB in Uganda. This evidence highlights the potential of digital technologies to improve treatment adherence monitoring and support in high TB burden settings with limited human resources.
ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689.
Journal Article
Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South Africa: Randomized Controlled Trial
by
Stewart-Isherwood, Lynsey
,
Carmona, Sergio
,
Fischer, Alex
in
Acquired immune deficiency syndrome
,
Adolescent
,
Adult
2019
South Africa provides free antiretroviral therapy for almost 5 million people living with HIV, but only 71% of the eligible people are on treatment, representing a shortfall in the care cascade, especially among men and youth. Many developing countries have expanded access to smartphones; success in health apps raises the possibility of improving this cascade.
SmartLink is a health app for Android smartphones providing HIV-related laboratory results, information, support, and appointment reminders to engage and link patients to care. This study aimed to evaluate the ability of SmartLink to improve linkage to care for HIV-positive smartphone owners.
This study was a multisite randomized controlled trial in Johannesburg. The intervention arm received the app (along with referral to a treatment site) and the control arm received the standard of care (referral alone). Linkage to care was confirmed by an HIV-related blood test reported on the National Health Laboratory Service database between 2 weeks and 8 months after initiation.
A total of 345 participants were recruited into the study; 64.9% (224/345) of the participants were female and 44.1% (152/345) were aged less than 30 years. In addition, 46.7% (161/345) were employed full time, 95.9% (331/345) had at least secondary school education, and 35.9% (124/345) were from Zimbabwe. Linkage to care between 2 weeks and 8 months was 48.6% (88/181) in the intervention arm versus 45.1% (74/164) in the control (P=.52) and increased to 64.1% (116/181) and 61.0% (100/164) (P=.55), respectively, after the initial 8-month period. Moreover, youth aged 18 to 30-years showed a statistically significant 20% increase in linkage to care for the intervention group.
Youth aged less than 30 years have been historically difficult to reach with traditional interventions, and the SmartLink app provides a proof of concept that this population reacts to mobile health interventions that engage patients in HIV care.
ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW).
Journal Article
Comparing the effectiveness of emotion regulation therapy and cognitive behavioral therapy on treatment adherence in hemodialysis patients: A randomized controlled clinical trial
by
Tarrahi, Mohammad Javad
,
Salimi Arshad Moghaddam Pishkhani, Seyedeh Hanieh
,
Zargar, Fatemeh
in
Adult
,
Aged
,
Behavior
2025
Non-adherence is a common challenge among patients undergoing hemodialysis (HD). This randomized controlled trial compared the efficacy of Emotion Regulation Therapy (ERT) and Cognitive Behavioral Therapy (CBT) on improving treatment adherence in hemodialysis patients, with a control group receiving standard care.
Ninety hemodialysis patients were equally randomized into ERT, CBT, and control groups (N = 30 each group), with six attrition cases per group. Baseline demographics (age, BMI, dialysis duration, education) showed no significant intergroup differences (p > 0.05). Adherence was assessed across five domains: dialysis, medication, fluid intake, dietary regimen, and total adherence. A MANCOVA/ANCOVA model analyzed changes at pre-intervention, post-intervention, and 3-month follow-up, controlling for baseline characteristics.
Both intervention groups demonstrated significant adherence improvements post-treatment versus controls (P < 0.001). CBT showed superior immediate effects, with total adherence scores increasing from 836.66 ± 192.95 to 1073.33 ± 89.28 (Δ + 28.3%), while ERT improved from 833.33 ± 210.53 to 920.00 ± 181.04 (Δ + 10.4%). At follow-up, CBT maintained higher adherence (1050.83 ± 93.88 vs. ERT's 890.00 ± 155.30), though both groups experienced dialysis adherence declines from post-treatment peaks (CBT: 580 to 574.16; ERT: 520 to 483.33). Control group adherence deteriorated across all domains (total: 911.66 to 835.00). Time-intervention interactions were significant for total adherence (P < 0.001), dialysis (P = 0.006), and medication adherence (P < 0.001), with largest CBT effects on fluid restriction adherence (Δ + 56.1% vs. ERT's Δ + 8.3%).
While both therapies enhanced adherence, CBT produced greater short-term improvements, particularly in behavioral domains (fluid/dietary compliance), whereas ERT showed better maintenance of medication adherence. The differential trajectory patterns suggest CBT's structured behavioral strategies may offer immediate benefits, while ERT's emotion-focused techniques could support longer-term regimen acceptance. Integration of both approaches into renal care protocols may optimize adherence outcomes.
Journal Article