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MBSR on Physiological and Psychological Factors in Patients With HF (MBSR-PP-HF)

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

The experimental group used App for MBSR intervention

the "Heart Care Life" app

Phone interview once a week

About this trial

This is an interventional other trial for Heart Failure focused on measuring Mindfulness-based stress reduction, Application, Resilience, Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) The diagnosis of heart failure is confirmed by a clinician, and the definition of the diagnosis is based on the international statistical classification of diseases and related health problems 10th revision (ICD-10), including I50 Heart failure ( heart failure) related diagnostic codes. (2) Legally recognized as an adult ≧ 18 years old. (3) The second part of the experimental research, in addition to the above inclusion conditions, also needs to have a patient health questionnaire ≥ 5 points, which means mild or above (including) depression (Kroenke et al., 2001; Yeung et al., 2008) can be included in the study. Exclusion Criteria: (1) Diagnosed by a physician as having depression or taking antidepressant drugs regularly, such as selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA), monoamine oxidase inhibitors (monoamine oxidase inhibitor, MAOI), tetracyclic antidepressants (TeCA), norepinephrine And specific serotonergic antidepressants (Noradrenergic and specific serotonergic antidepressants, NaSSA). (2) New York heart association functional classification (NYHA Fc) IV, which means that it is uncomfortable to perform any physical activity, even when lying in bed or moving, you may feel symptoms such as dyspnea or palpitations. (3) Those who still need to use oxygen or breathing aids throughout the day. (4) Those who are still equipped with ventricular assist devices and rely on life-support devices. (5) Activities of daily living (ADL) < 60 points, unable to take care of themselves in daily life. (6) For those with abnormal cognitive function, the mini-mental state examination (MMSE) < 24 points. (7) Those who have undergone heart transplantation have lost innervation because there is no connection between the autonomic nerve and the heart (McCraty & Shaffer, 2015). (8) In the second part of the interventional experimental research, in addition to the above exclusion conditions, in order to avoid interference with the research, it is also necessary to exclude: A. Those who cannot read traditional Chinese or communicate in Mandarin or Taiwanese, because health education-related materials, videos and applications are all in traditional Chinese. B. Those who cannot use Android devices at home with smartphones or tablets need to operate the application at home due to intervention measures. C. Those who have regularly taken measures related to mindfulness, meditation, and sitting meditation in the past year are not included in order to avoid interfering with the research results.

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MBSR

waiting list

Arm Description

The experimental group used App for MBSR intervention The main app of this experiment is "Mindfulness in life (Taiwan)" (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practising audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate.

The waiting list used only the Heart Care Life app for the first eight weeks, as self-management is an essential element of heart failure treatment (Tsami et al., 2023), following the situation-specific theory of heart failure self-management (the situation- specific theory of heart failure self-care:) (Riegel et al., 2022) and American heart failure guidelines (Heidenreich et al., 2022) design (Tsami et al., 2023; Vellone et al., 2020), mainly for Disease-related knowledge and self-management tools, built-in disease health education electronic audiobooks, diet sodium content calculator, diet water content calculator, activity step calculation, etc., to help research subjects self-manage the disease. Measure T2 at week 8. From the ninth to the sixteenth week, use the Mindful Live app.

Outcomes

Primary Outcome Measures

quality of life (SF-12v2）

short-form health survey (SF-12v2）, Cronbach's α = 0.76～0.85.

Secondary Outcome Measures

depression

patient health questionnaire (PHQ-9）, Cronbach's α = 0.84

mindfulness

five facet mindfulness questionnaire-short form (FFMQ-SF）, Cronbach's α= 0.69～0.85.

Resilience

Connor-Davidson resilience scale (CD-RISC-10）, Cronbach's α = 0.94

Full Information

NCT ID

NCT05967247

First Posted

July 21, 2023

Last Updated

September 24, 2023

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05967247

Brief Title

MBSR on Physiological and Psychological Factors in Patients With HF

Acronym

MBSR-PP-HF

Official Title

The Effect of App-Based Mindfulness-Based Stress on Physiological and Psychological Factors in Patients With Heart Failure: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 18, 2023 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Objective The purpose of this study is to explore the relationship between mindfulness, resilience, depression and quality of life in patients with heart failure, and the effect of mindfulness-based stress reduction intervention with mobile phone application on subjects with depressive symptoms. Therefore, the research objectives are as follows: To explore the relationship between mindfulness, resilience, depression, and quality of life in patients with heart failure, and to explore the mediating role of positive emotions (mindfulness, resilience). Using a mobile phone app to conduct mindfulness-based stress reduction interventions, to explore the effects of physiological and psychological factors in heart failure patients with depressive symptoms. Methods This study will be conducted in two parts. The first part will be a cross-sectional study. It is planned to be conducted in the cardiology ward or outpatient clinic of a university-affiliated hospital in northern Taiwan between September and December 2023 after the approval of the Human Experiment Ethics Committee. Contact the patients who meet the research conditions, adopt the intentional sampling method, and plan to accept 180 research objects for the questionnaire survey, the collection tools are the basic information of the research objects, mindfulness, resilience, depression, quality of life scale; in the first part, the patients' Health Questionnaire (patient health questionnaire-9, PHQ-9) was used to screen for depressive symptoms, and when the total score ≧ 5 points, they were invited to participate in the second part of the study. The second part plans to include 68 subjects in the study, adopting a single-blind random allocation waiting list design, using the app designed by the researcher to implement the mindfulness-based stress reduction intervention program, which is planned to be carried out for 8 weeks, and since the beginning of the study, the 8th week (After the intervention in the experimental group), and the 16th week (after the intervention in the control group), a total of three research data collections were carried out.

Detailed Description

Expected research results The expected results of the first part of the research are that the research subjects with higher mindfulness have less depression, higher resilience, and better quality of life, and the mindfulness of the research subjects can play a mediating role between depression and quality of life; the second part expects the research subjects After receiving the intervention of mindfulness-based stress reduction on the mobile phone application, it can increase their mindfulness, resilience and quality of life, reduce depression, blood pressure, and improve heart rate variability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Mindfulness-based stress reduction, Application, Resilience, Heart failure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

Participant

Masking Description

Difficult to blind study caregivers and study outcome assessors due to the nature of the mindfulness-based stress reduction intervention

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MBSR

Arm Type

Experimental

Arm Description

Arm Title

waiting list

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

The experimental group used App for MBSR intervention

Other Intervention Name(s)

Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.

Intervention Description

The experimental group used App for MBSR intervention The main app of this experiment is "Mindfulness in Life (Taiwan)" (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practicing audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate.

Intervention Type

Other

Intervention Name(s)

the "Heart Care Life" app

Intervention Description

Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.

Intervention Type

Other

Intervention Name(s)

Phone interview once a week

Intervention Description

Phone interview once a week

Primary Outcome Measure Information:

Title

quality of life (SF-12v2）

Description

short-form health survey (SF-12v2）, Cronbach's α = 0.76～0.85.

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Secondary Outcome Measure Information:

Title

depression

Description

patient health questionnaire (PHQ-9）, Cronbach's α = 0.84

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Title

mindfulness

Description

five facet mindfulness questionnaire-short form (FFMQ-SF）, Cronbach's α= 0.69～0.85.

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Title

Resilience

Description

Connor-Davidson resilience scale (CD-RISC-10）, Cronbach's α = 0.94

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Other Pre-specified Outcome Measures:

Title

medication adherence

Description

Medication Adherence Self-Reported by Patient

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Title

Heart rate variability (HRV)

Description

Measured with a non-plunging wrist-worn instrument

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Title

heart rate (pulse)

Description

Measured according to the blood pressure measuring instrument regularly calibrated by the hospital

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

Title

blood pressure (BP)

Description

Measured according to the blood pressure measuring instrument regularly calibrated by the hospital

Time Frame

T0, T1 = 8 weeks, T2 = 16 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shu-Ling Wang, RN

Phone

+886223123456

Ext

263205

cryetaljessie@ntuh.gov.tw

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100225

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shu-Ling Wang, RN

Phone

+866223123456

Ext

263205

crystaljessie@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

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Links:

URL

https://orcid.org/0000-0002-0678-2264

Description

Chih-fan Yeh

URL

https://orcid.org/0000-0002-1062-8307

Description

Chia-Jung Hsieh

URL

https://orcid.org/0000-0002-4336-765X

Description

Shu-Ling Wang

Learn more about this trial

MBSR on Physiological and Psychological Factors in Patients With HF

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