A Randomized Trial on Breast Self-Examination in Faenza (Northern-Italy)

Aims and background The aim of this randomized controlled trial was to compare two methods for teaching breast self-examination: theoretical and practical session versus mailed material. Methods A random sample of women aged 20-64 years was drawn from the demographic file of the city of Faenza (Northern-Italy). Of 825 sampled eligible women, 168 declined participation, 657 were randomly assigned, after completing a pretest questionnaire aimed at evaluating practice and quality of breast self-examination. Individualised instruction was administered to the treatment group invited to be taught breast self-examination in a medical practice setting. The control group received mailed information about breast self-examination. One year later, 443 women completed the posttest questionnaire. Results As far as concerns the first outcome of the trial (change in practice of breast-self examination) our study showed, after adjusting for lost-to-follow-up, no difference between the treatment and the control group. The analysis performed to evaluate the second outcome (change in quality of breast self-examination practice) showed that women of the treatment group improved the quality of breast self-examination practice more than the control group (Wilcoxon test, z=2.4, P<0.01). The same results have been confirmed by multiple regression analyses taking into account all potential confoun-ders. No selection bias affected these results. Conclusion Theoretical and practical sessions resulted in an improved quality of examination technique than did mailed material.

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PEMBERIAN TERAPI MURATTAL AL-QURAN TERHADAP KUALITAS TIDUR IBU HAMIL PRIMIGRAVIDA TRIMESTER III

Jurnal Kebidanan Malahayati ◽

10.33024/jkm.v7i2.3970 ◽

2021 ◽

Vol 7 (2) ◽

pp. 287-294

Author(s):

Noviyanti Noviyanti ◽

Rahmi Rahmi ◽

Ratna Dewi ◽

Nurdahliana Nurdahliana

Keyword(s):

Treatment Group ◽

Sleep Quality ◽

Pregnant Women ◽

Wilcoxon Test ◽

Control Group ◽

Third Trimester ◽

Control Group Design ◽

Group Design ◽

The Third

GIVING MURATTAL AL-QURAN THERAPY ON QUALITY TRIMESTER PRIMARY PREGNANT MOTHER'S SLEEP III Background : Expecting mothers experienced different discomforts which were frequently felt in the third trimester, a waiting period in which the pregnant mothers started to be alert of delivering a baby. These discomforts resulted in disturbance of activities of the expectants. Sleep problem was mostly occured during this trimester which might decrease sleep quality. To overcome the complaint, there should be a way to increase sleep quality of the pregnant women. One of them is Murattal Qur'an.Purpose : This study was aimed at finding out the effect of Murattal Qur'an on third semester toward sleep quality of the pregnants.Methods : This research belonged to a quasi-experimental with a pretest-posttest control group design. The population in this study were all pregnant women in the third trimester primigravida in the working area of the Kuta Baro Health Center, Aceh Besar. The sample was 40 pregnant women who were divided into the control group and the treatment group. The treatment group listened to the Murattal Quran chapter Ar-Rahman on Android for 7 nights before going to bed. Data was analysed by using the Wilcoxon test because the data were not normally distributed.Results : The obtained significant value (p) of the treatment group of before and after therapy was 0.000 lower than 0.05 (p=0.000 <0.05)Conclusion : There is an effect of giving Murattal Al-Quran therapy in the third trimester primigravida on the quality of mother's sleep.Suggestion : It hoped that it increased the active role of Midwives to provide information to pregnant women about the way to overcome the sleep disorders of the third trimester pregnant women was by by listening to the murattal Quran. Keywords: Murattal Al-Quran, Sleep Quality, Primigravida, Third Trimester.ABSTRAK Latar Belakang : Ketidaknyamanan yang dirasakan oleh ibu hamil paling sering dirasakan saat trimester III. Trimester III merupakan masa menunggu kelahiran bayinya. Ketidaknyamanan yang dirasakan ibu mengakibatkan aktivitas sehari-hari ibu hamil menjadi terganggu. Gangguan tidur merupakan Keluhan yang paling sering terjadi pada ibu hamil trimester III. Gangguan ini menyebabkan kualitas tidur ibu menurun. Salah satu cara pendekatan untuk meningkatkan kualitas tidur ibu hamil adalah mendengarkan lantunan ayat Al-Quran.Tujuan : Mengetahui pengaruh pemberian terapi murattal Al-Quran pada primigravida trimester III terhadap kualitas tidur ibu.Metode : Jenis penelitian adalah quasi-eksperimen dengan pendekatan pretest-posttest control group design. Populasi adalah primigravida trimester III di wilayah kerja Puskesmas Kuta Baro Kabupaten Aceh Besar. Jumlah sampel 40 ibu hamil yang dibagi menjadi kelompok kontrol dan kelompok perlakuan. Kelompok perlakuan mendengarkan murattal Al-Quran surah Ar-Rahman dengan menggunakan HP Android selama 7 malam sebelum tidur. Analisa data menggunakan Uji Wilcoxon karena data berdistribusi tidak normal.Hasil : Nilai signifikan pada kelompok perlakuan terhadap kualitas tidur ibu sebelum dan sesudah diberikan terapi adalah p = 0,000 lebih kecil dari nilai 0,05.Kesimpulan : Terdapat pengaruh pemberian terapi murattal Al-Quran pada primigravida trimester III terhadap kualitas tidur ibu.Saran : Meningkatkan peran aktif bidan dalam memberikan informasi kepada ibu hamil tentang asuhan ketidaknyaman ibu hamil trimester III yaitu masalah gangguan tidur dengan mendengarkan murattal Al-Quran. Kata Kunci: Murattal Al-Quran, Kualitas tidur, Primigravida, Trimester III.

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Effects of Counselling on Quality of Life among Cancer Patients in Malaysia: A Randomized Controlled Trial

Iranian Journal of Public Health ◽

10.18502/ijph.v49i10.4693 ◽

2020 ◽

Author(s):

Ummavathy PERIASAMY ◽

Sherina MOHD-SIDIK ◽

Mehrnoosh AKHTARI- ZAVARE ◽

Lekhraj RAMPAL ◽

Siti Irma Fadhilah ISMAIL ◽

...

Keyword(s):

Quality Of Life ◽

Treatment Group ◽

Cancer Patients ◽

Psychological Health ◽

Controlled Trial ◽

Peninsular Malaysia ◽

Public Hospitals ◽

Repeated Measure ◽

Control Group

Background: We aimed to assess whether “Managing Patients on Chemotherapy” book is effective to improve quality of life (QOL) of cancer patient via counselling by pharmacist. Methods: A randomized control trial study was run among 2120 cancer patients in public hospitals in Peninsular Malaysia, from Apr 2016-Jan 2018. The treatment group received counselling regarding chemotherapy by using developed module. The data were collected at three time-points: baseline, 1st, 2nd and 3rd follow-ups after counseling by Validated Malay version of the WHOQOL-BREF of questionnaire. Data analyses were done using χ2 and two-way repeated measure ANOVA. Results: The treatment group improved significantly as compared to control group in physical health, psychological health, social relationship, environment and overall QOL (P<0.00). Conclusion: The “Managing Patients on Chemotherapy” book along with repetitive counselling by pharmacists is a useful intervention for improving QOL of cancer patients undergoing treatment.

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Psychoeducation Group on Improving Quality of Life of Mild Cognitive Impaired Elderly

Research on Social Work Practice ◽

10.1177/1049731517732420 ◽

2017 ◽

Vol 29 (3) ◽

pp. 303-310 ◽

Cited By ~ 1

Author(s):

Daniel Kim-wan Young ◽

Petrus Yat-nam Ng ◽

Daphne Cheng

Keyword(s):

Quality Of Life ◽

Treatment Group ◽

Controlled Trial ◽

T Test ◽

World Health ◽

Control Group ◽

World Health Organization Quality ◽

Life Measure ◽

Health Organization

Purpose: This research study aims to evaluate the effectiveness of a psychoeducation group, which is founded on an Eastern approach to health care, in improving the quality of life of Chinese people with mild cognitive impairment (PwMCI). Method: In a randomized controlled trial (RCT), 40 Chinese PwMCI were randomly assigned to either a 10-session psychoeducation group or the control group. Results: A paired sample t test indicated that the treatment group ( n = 18) showed significant improvement in their World Health Organization Quality of Life Measure (WHOQOL) score, while the control group ( n = 22) did not. Moreover, an independent t test showed that the treatment group was more effective than the control group to improve their WHOQOL score. A reduction in the depressive symptoms was related to the improvement in WHOQOL score. Conclusions: This RCT provides evidence to support the feasibility and effectiveness of psychoeducation groups for improving the overall quality of life of PwMCI.

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Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome

Canadian Journal of Kidney Health and Disease ◽

10.1177/2054358120951390 ◽

2020 ◽

Vol 7 ◽

pp. 205435812095139

Author(s):

Bhanu Prasad ◽

Maryam Jafari ◽

Kaval Kour ◽

Kunal Goyal ◽

Francisco Garcia

Keyword(s):

Treatment Group ◽

Renal Denervation ◽

Controlled Trial ◽

Feasibility Trial ◽

Control Group ◽

Single Center ◽

Randomized Controlled ◽

Loin Pain

Background: Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial. Objective: The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients. Design: Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients. Setting: Regina General Hospital in Regina, Saskatchewan, Canada. Patients: Ten LPHS patients who require opioid therapy. Measurements: The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively. Methods: Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients. Limitations: Single-center study, small sample size. Conclusions: The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients. Trial registration: ClinicalTrials.gov (NCT04332731).

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Acupuncture for osteoporosis: study protocol for a randomized controlled trial

10.21203/rs.2.24690/v1 ◽

2020 ◽

Author(s):

M Huang ◽

MX Lai ◽

XY Wang ◽

YF Wang ◽

J Yang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Primary Osteoporosis ◽

Randomized Controlled ◽

Acupuncture And Moxibustion ◽

One Year ◽

Experimental Group

Abstract Background: The rapid increase in the prevalence of osteoporosis and the rate of fractures after osteoporosis indicates that osteoporosis has become a serious global public health problem. A recent meta-analysis showed that oral alendronate and parenteral injection of zoledronate had no statistical significance in preventing postmenopausal hip fractures. Acupuncture and moxibustion are widely used in the treatment of osteoporosis due to their good analgesic effects. Early observation showed that integral adjustment of acupuncture and moxibustion therapy could improve the quality of life of patients with osteoporosis and prevent the occurrence of osteoporosis fractures. As the observation period of fracture is too long, it is necessary to carry out a large and strictly designed multi-center randomized trial covering the risk factors of fracture and fracture induction, so as to evaluate the effectiveness of acupuncture and moxibustion in the treatment of primary osteoporosis.Methods/Design: A multicenter randomized controlled trial will be performed in three hospitals. 312 participants patients within primary osteoporosis will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture and western medicine while the control group is treated with Western medicine. All the patients will receive a 3-month treatment and 6-month,and one year follow-ups. The primary outcome is the bone mineral density (BMD), the secondary outcome is Bone-derived alkaline phosphatase(BALP), bone glaprotein(BGP), visual pain scale score(VAS),Traditional Chinese Medicine (TCM) syndrome scores, quality of daily life score(QOL) and adverse events. Outcome measures (including primary and secondary outcome measures) are collected at baseline,3 months of the intervention, Causes and number of falls are collected at 6 months and one year after the intervention.Discussion: This study will provide clinical evidence for the treatment of primary osteoporosis with holistic adjustment acupuncture. This study will evaluate the synergistic effect of acupuncture treatment for primary osteoporosis and provide evidence for clinical treatment.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.

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The Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-Management of Irritable Bowel Syndrome: a Cross-Over, Randomized Controlled Trial (Preprint)

10.2196/preprints.26152 ◽

2020 ◽

Author(s):

Melissa Hunt ◽

Sofia Miguez ◽

Benji Dukas ◽

Obinna Onwude ◽

Sarah White

Keyword(s):

Irritable Bowel Syndrome ◽

Treatment Group ◽

Controlled Trial ◽

Post Treatment ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Irritable Bowel ◽

Intent To Treat

BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety which can result in reduced productivity and impaired health related quality of life (HRQL). Cognitive-behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have the potential to increase access to guided CBT at scale but require careful study to assess their benefits and risks. OBJECTIVE To test the efficacy of a novel app, Zemedy - a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a cross-over randomized controlled trial (registration number NCT04170686). Participants were recruited online. Patients were randomly allocated to either immediate treatment (N = 62) or waitlist control (N = 59). The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy and behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life (IBS-QoL), Gastrointestinal Symptom Rating Scale (GSRS)) and secondary outcome measures (the Fear of Food Questionnaire (FFQ), the Visceral Sensitivity Index (VSI), the GI Cognition Questionnaire (GI-COG), the Depression, Anxiety Stress Scale (DASS) and the Patient Health Questionnaire (PHQ-9)). Waitlist controls were then offered the opportunity to cross over. All participants were assessed one more time at 3 months post-treatment completion. RESULTS Both intent-to-treat and completer analyses at post-treatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months post-treatment. Scores on the GSRS, IBS-QoL, GI-COG, and VSI all improved significantly more in the treatment group [F(1,79) = 20.49, P < .001, Cohen’s d = 1.01; F(1,79) = 20.12, P < .001, d = 1.25; F(1,79) = 34.71, P < .001, d = 1.47 and F(1,79) = 18.7, P < .001, d = 1.07]. Fear of food also decreased for the treatment group relative to the control group [F(1,79) = 12.13, P = .001, d = .62]. Depression improved significantly as measured by both the PHQ9 [F(1,79) = 10.5, P = .002, d = 1.07] and the DASS Depression Subscale [F(1,79) = 6.03, P = .016, d = .83], as did the stress subscale of the DASS [F(1,79) = 4.47, P = .04, d = .65] in the completer analysis but not the intent-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence based treatment. CLINICALTRIAL This trial was registered at ClinicalTrials.gov as NCT04170686

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Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05228-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Ye ◽

Dawei Zhu ◽

Siyuan Chen ◽

Xuefeng Shi ◽

Rui Gong ◽

...

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Cost Effectiveness ◽

Treatment Group ◽

Hearing Aids ◽

Control Group ◽

Chinese Adults ◽

Community Based ◽

The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

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The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial

Trials ◽

10.1186/s13063-021-05166-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jae Yen Song ◽

Hoon Choi ◽

Minsuk Chae ◽

Jemin Ko ◽

Young Eun Moon

Keyword(s):

General Anesthesia ◽

Assessment Tool ◽

Controlled Trial ◽

Perioperative Period ◽

Postoperative Outcomes ◽

Control Group ◽

Quality Of Recovery ◽

Gynecological Laparoscopy ◽

Prospective Randomized Controlled Trial

Abstract Background Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods The participants (n = 78) will be allocated to one of the two groups; the study group will receive bolus and infusion of dexmedetomidine and lidocaine, and the control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in the two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, and opioid-related side effects will be assessed. Additionally, an ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during the study period. Discussion This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA. Trial registration ClinicalTrials.gov NCT04409964. Registered on 28 May 2020

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Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04140-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Marco Monticone ◽

Igor Portoghese ◽

Daniele Cazzaniga ◽

Valentina Liquori ◽

Giuseppe Marongiu ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Rehabilitation Program ◽

Group Differences ◽

Randomized Controlled ◽

Secondary Outcomes ◽

One Year ◽

Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

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Long-term effectiveness of telephone-based health coaching for heart failure patients: A post-only randomised controlled trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x16668436 ◽

2016 ◽

Vol 23 (8) ◽

pp. 716-724 ◽

Cited By ~ 11

Author(s):

Michel Tiede ◽

Sarah Dwinger ◽

Lutz Herbarth ◽

Martin Härter ◽

Jörg Dirmaier

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Locus Of Control ◽

Controlled Trial ◽

Health Coaching ◽

Analysis Of Covariance ◽

Control Group ◽

Heart Failure Patients ◽

Health Related

Introduction The * Equal contributors. health-status of heart failure patients can be improved to some extent by disease self-management. One method of developing such skills is telephone-based health coaching. However, the effects of telephone-based health coaching remain inconclusive. The aim of this study was to evaluate the effects of telephone-based health coaching for people with heart failure. Methods A total sample of 7186 patients with various chronic diseases was randomly assigned to either the coaching or the control group. Then 184 patients with heart failure were selected by International Classification of Diseases (ICD)-10 code for subgroup analysis. Data were collected at 24 and 48 months after the beginning of the coaching. The primary outcome was change in quality of life. Secondary outcomes were changes in depression and anxiety, health-related control beliefs, control preference, health risk behaviour and health-related behaviours. Statistical analyses included a per-protocol evaluation, employing analysis of variance and analysis of covariance (ANCOVA) as well as Mann-Whitney U tests. Results Participants’ average age was 73 years (standard deviation (SD) = 9) and the majority were women (52.8%). In ANCOVA analyses there were no significant differences between groups for the change in quality of life (QoL). However, the coaching group reported a significantly higher level of physical activity ( p = 0.03), lower intake of non-prescribed drugs ( p = 0.04) and lower levels of stress ( p = 0.02) than the control group. Mann-Whitney U tests showed a different external locus of control ( p = 0.014), and higher reduction in unhealthy nutrition ( p = 0.019), physical inactivity ( p = 0.004) and stress ( p = 0.028). Discussion Our results suggest that telephone-based health coaching has no effect on QoL, anxiety and depression of heart failure patients, but helps in improving certain risk behaviours and changes the locus of control to be more externalised.

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