Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

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Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.30191 ◽

2021 ◽

Author(s):

Mohammad Habibur Rahman Sarker ◽

Michiko Moriyama ◽

Harun Ur Rashid ◽

Md Moshiur Rahman ◽

Mohammod Jobayer Chisti ◽

...

Keyword(s):

Quality Of Life ◽

Chronic Kidney Disease ◽

Randomized Controlled Trial ◽

Kidney Disease ◽

Health Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191

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Efficacy and cost-utility of the eHealth application ‘Oncokompas’, supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial

BMC Palliative Care ◽

10.1186/s12904-019-0468-8 ◽

2019 ◽

Vol 18 (1) ◽

Cited By ~ 4

Author(s):

Anouk S. Schuit ◽

Karen Holtmaat ◽

Nienke Hooghiemstra ◽

Femke Jansen ◽

Birgit I. Lissenberg-Witte ◽

...

Keyword(s):

Quality Of Life ◽

Palliative Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cost Utility ◽

Control Group ◽

Incurable Cancer ◽

Randomized Controlled

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.

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The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: a randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03674-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sepideh Dinmohammadi ◽

Mohsen Dadashi ◽

Elahe Ahmadnia ◽

Leila Janani ◽

Roghieh Kharaghani

Keyword(s):

Quality Of Life ◽

Domestic Violence ◽

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Solution Focused

Abstract Background Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence. Methods A randomized controlled trial on 90 pregnant women was blocked into two intervention groups (n = 45) and a control (n = 45). The intervention group received six counseling sessions with a solution-focused approach. Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The tools were completed once before the intervention and again 6 weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant. Results A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps = 0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P = 0.001). Conclusion Solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence. Trial registration Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

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Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

10.21203/rs.3.rs-19471/v1 ◽

2020 ◽

Author(s):

Toshimi Takano ◽

Ayako Matsuda ◽

Noriko Ishizuka ◽

Yukinori Ozaki ◽

Koichi Suyama ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Cancer Patients ◽

Emotional Functioning ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

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Improving Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea With An Intervention Based On Stratification and Personalization of Care Plans: A Randomized Controlled Trial

10.21203/rs.3.rs-757639/v1 ◽

2021 ◽

Author(s):

David Rudilla ◽

Salvador Perelló ◽

Pedro Landete ◽

Enrique Zamora ◽

María Vázquez ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Care Plans ◽

Randomized Controlled ◽

Individualized Care ◽

Health Related

Abstract Purpose The aim was to determine adherence to CPAP and health-related outcomes in patients with OSA via a comprehensive program based on stratification and individualized care plans, including motivational interview. Methods A multicentre, randomized controlled trial (RCT) design was used in 3 hospitals. The control group followed the usual treatment. Intervention group (PIMA) followed the treatment with an adapted care plan (home visits, telephone, care-center) depending on socio-demographic, clinical and psychological variables, using motivational interviews in all the interventions. The main outcome was adherence, and secondary were quality of life, emotional state, activities, social relationships, perceived competence, and motivation. The clinical trial was registered with www.clinicaltrials.gov (NCT 04691479). Results 213 patients (68.1% men, 58.7% between 51–69 years old, 45.5% upper-secondary school education) were randomized: 108 were in the intervention group and 105 were in the control group. The result showed a statistically significant difference in adherence at 90 and 180 days respectively: 129.24 (IC 95% 77.25-181.22) p < 0.0001 and 288.30 (IC95% 187.146–389.47) p < 0.0001. The adherence (hours/day) showed favourable results for the PIMA group compared to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18–2.30) p < 0.0001 and at 180 days with a difference of 2.31 (IC95% 1.72–2.91) p < 0.001. The results for secondary outcomes also showed statistically significant differences in favour of the PIMA group. Conclusions This study found evidence that a program based on stratification and personalized care plans, through motivational interviewing, improves adherence to CPAP treatment and health-related outcomes than traditional care.

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Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/30191 ◽

2021 ◽

Vol 10 (11) ◽

pp. e30191

Author(s):

Mohammad Habibur Rahman Sarker ◽

Michiko Moriyama ◽

Harun Ur Rashid ◽

Md Moshiur Rahman ◽

Mohammod Jobayer Chisti ◽

...

Keyword(s):

Quality Of Life ◽

Chronic Kidney Disease ◽

Randomized Controlled Trial ◽

Kidney Disease ◽

Health Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

Background Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. Objective The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. Methods A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. Results Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. Conclusions It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. Trial Registration ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 International Registered Report Identifier (IRRID) DERR1-10.2196/30191

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Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15001 ◽

2020 ◽

Vol 22 (6) ◽

pp. e15001

Author(s):

Sarah MacLean ◽

Daniel J Corsi ◽

Sadie Litchfield ◽

Julia Kucharski ◽

Kira Genise ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

10.2196/preprints.15001 ◽

2019 ◽

Author(s):

Sarah MacLean ◽

Daniel J. Corsi ◽

Sadie Litchfield ◽

Julia Kucharski ◽

Kira Genise ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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Home-based Palliative Intervention to Improve Quality of Life in Children with Cancer: A Randomized Controlled Trial

10.21203/rs.2.18923/v1 ◽

2019 ◽

Author(s):

Murti Andriastuti ◽

Pricilia G Halim ◽

Elnino Tunjungsari ◽

Dwi P Widodo

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Children With Cancer ◽

Randomized Controlled ◽

Home Based ◽

Significant Difference

Abstract Background: In these last few years, an integrated approach between palliative care (PC) and chronic and/or life-threatening conditions care have been widely used. Home-based PC service is developed to meet the needs of the patients at home, but hasn’t been applied widely. This study is aimed to determine the benefit of integrated home-based PC in the quality of life (QOL) and symtomps intensity of Indonesian children with malignancies. Method: A randomized controlled trial to compare the quality of life between patients who were given PC (a 3-month home visit) and those who were not (intervention vs control group) was conducted, each group containing 30 children with cancer aged 2-18 years old who were consulted to palliative team. Participants were randomly assigned into each group. In the first and twelfth week of the intervention, all patients were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0 (report by proxy or self-report). Symptoms intensity (pain, anorexia, sleep disturbance) were scored by using Edmonton Symptoms Assessment Scale (ESAS). Mean score and each dimension score of both group were compared and analyzed using bivariate analysis. Results: A total 50 participants were included in analysis. Significant difference was found between two groups with average total score in control group 62.39 and intervention group 81.63 (p<0.001). In the intervention group QoL tends to improve, whereas in the control group, those did not get palliative intervention, quality of life tends to decrease as the disease progress. The most improved aspect in QoL is pain and nausea (p<0.001), followed by procedural anxiety (p=0.002), treatment anxiety (p=0.002), and worry (p=0.014). Palliative intervention was found to be able to reduce sleep disturbances (p=0.003) and anorexia (p<0.001) significantly. Conclusion: Home-based PC improved several aspects of the QOL and provide better symptoms management of children with malignancies. An early intervention concurrent with the underlying treatment is believed to be able to improve their quality of life. Trial Registration: This study has been retrospectively registered in ClinicalTrials.gov ID: NCT04067687 (August, 22nd 2019).

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Effect of the fourth generation multi-theory model intervention on the quality of life in Iranian postmenopausal women: A randomized controlled trial

Post Reproductive Health ◽

10.1177/20533691211042164 ◽

2021 ◽

pp. 205336912110421

Author(s):

Nooshin Yoshany ◽

Mohammad Ali Morowatisharifabad ◽

Narjes Bahri ◽

Sara Jambarsang ◽

Manoj Sharma ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Theory Model ◽

Control Group ◽

Randomized Controlled ◽

Menopausal Women

Objectives Menopause is a natural part of women’s lives and is associated with a series of complications that can impair their quality of life. This study was conducted to determine the effect of specific educational interventions on the quality of life among postmenopausal women. Methods This randomized controlled trial was conducted on 80 menopausal women who met the inclusion and exclusion criteria and were selected through the multi-stage stratified random sampling method. The participants were randomly allocated to either the control or intervention group (40 per group). The intervention comprised 5 × 45-min educational sessions based on the Multi-Theory Model on the predetermined days of the week. The scores of the quality of life level were collected at baseline, immediately, and 3 months after the intervention using the Menopause-Specific Quality of Life questionnaire (MENQOL). The control group received a health advice. Results Analysis of variance of repeated measures showed a significant interaction between time and intervention. The comparison between the mean score of quality of life of the “before,” “immediately after intervention,” and “3 months after the intervention” showed a significant difference between the two groups. The intervention group quality of life improved significantly as the intervention went on compared to the control group. Conclusion Structured simple educational programs based on the Multi-Theory Model could be used as a simple and noninvasive intervention that help menopausal women improve their quality of life through menopausal symptoms relief. Further interventions with larger trials may be required to confirm these findings.

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