Usability and Clinical effectiveness of the NEVERMIND system

SND-ID: 2023-106-1. Version: 1. DOI: https://doi.org/10.48723/21y0-2g17

Associated documentation

Citation

Creator/Principal investigator(s)

Nuhamin Gebrewold Petros - Karolinska Institutet orcid

Research principal

Karolinska Institutet - Department of Learning, Informatics, Management and Ethics rorId

Description

The data provided is from the NEVERMIND trial, a randomized controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The dataset includes data on 255 patients diagnosed with breast cancer or prostate cancer who were randomly assigned to the NEVERMIND intervention or a control group. The data includes baseline sociodemographic data, structured questionnaires on mental health symptoms (Beck Depression Inventory-II and Depression, Anxiety and Stress Scale-21), acceptability and usability (System Usability Scale, user version of the Mobile Application Rating Scale, Perceived usefulness and Perceived ease of use) and recorded log data collected at 12 weeks to assess the effectiveness, usability, and acceptability of the NEVERMIND system.

The NEVERMIND system consists of a shirt and a smart phone. Sensors in the shirt and an application in the smart phone data collect data on the patient's condition.

The main purpose of the dataset is to investigate the relationship between the clinical effectiveness, us

... Show more..
The data provided is from the NEVERMIND trial, a randomized controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The dataset includes data on 255 patients diagnosed with breast cancer or prostate cancer who were randomly assigned to the NEVERMIND intervention or a control group. The data includes baseline sociodemographic data, structured questionnaires on mental health symptoms (Beck Depression Inventory-II and Depression, Anxiety and Stress Scale-21), acceptability and usability (System Usability Scale, user version of the Mobile Application Rating Scale, Perceived usefulness and Perceived ease of use) and recorded log data collected at 12 weeks to assess the effectiveness, usability, and acceptability of the NEVERMIND system.

The NEVERMIND system consists of a shirt and a smart phone. Sensors in the shirt and an application in the smart phone data collect data on the patient's condition.

The main purpose of the dataset is to investigate the relationship between the clinical effectiveness, usability, and acceptability of the NEVERMIND eHealth intervention for treating depressive and stress symptoms in breast and prostate cancer patients. Linear mixed model analyses and multiple regression were used to evaluate the association between clinical effectiveness, usability, and acceptability variables.

The dataset is relevant for reuse by researchers interested in investigating the effectiveness of eHealth interventions for treating depressive and stress symptoms in cancer patients.

The dataset consists of a file called dataset_usability_clinical_nevermind.xlsx, which contains a table with data collected from individuals in the study. A codebook file (Codebook.xlsx) is also included and defines the variables used in the table. Show less..

Data contains personal data

Yes

Sensitive personal data

Yes

Type of personal data

Residence, Age, Sex, Marital Status, Employment, Cancer Diagnosis

Code key exists

Yes

Language

Method and outcome

Unit of analysis

Population

255 patients diagnosed either with stage II, III, or IV breast or prostate cancer were randomly assigned to the NEVERMIND intervention or a control group.

Study design

Randomised controlled trial (RCT)

Description of study design

The study uses data from the NEVERMIND trial which is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The trial started in November 2016 and ended in June 2020. Enrollment of participants began December 2017 and last data collected was conducted in June 2020. The main RCT includes patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation, but this data document only includes breast and prostate cancer patients. Participants were randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, and at 12 weeks to assess whether the NEVERMIND system is superior to treatment as usual.

Sampling procedure

Breast and prostate cancer patients were recruited from the Piedmont Oncological Network, at San Luigi Gonzaga University Hospital, Turin, Italy and Breast Unit-Oncology Department and Urology Department at Città della Salute e della Scienza University Hospital, Turin, Italy. The departments are the main departments for the region, thus, patients come from all over the region to the clinical centres.

Time period(s) investigated

2016-11 – 2020-06

Variables

27

Number of individuals/objects

255

Data format / data structure

Data collection
Geographic coverage

Geographic spread

Geographic location: Italy, Western Europe

Geographic description: Data was recruited from patients in Turin, Italy.

Administrative information

Responsible department/unit

Department of Learning, Informatics, Management and Ethics

Ethics Review

Swedish Ethical Review Authority - Ref. 2020-04175

Topic and keywords

Research area

Medical and health sciences (Standard för svensk indelning av forskningsämnen 2011)

Public health, global health, social medicine and epidemiology (Standard för svensk indelning av forskningsämnen 2011)

Publications

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Petros, N., Hadlaczky, G., Carletto, S., Martinez, S., Ostacoli, L., Ottaviano, M., Meyer, B., Scilingo, E., & Carli, V. (n.d.). Sociodemographic Characteristics Associated With an eHealth System Designed to Reduce Depressive Symptoms Among Patients With Breast or Prostate Cancer: Prospective Study. In JMIR formative research (Vol. 6, Issue 6, pp. e33734-). https://doi.org/10.2196/33734
DOI: https://doi.org/10.2196/33734
SwePub: oai:prod.swepub.kib.ki.se:235675116

Carli, V., Petros, N., Hadlaczky, G., Vitcheva, T., Berchialla, P., Bianchi, S., Carletto, S., Christinaki, E., Citi, L., Dinis, S., Gentili, C., Geraldes, V., Giovinazzo, L., Gonzalez-Martinez, S., Meyer, B., Ostacoli, L., Ottaviano, M., Ouakinin, S., Papastylianou, T., … Valenza, G. (2022). The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial. In EClinicalMedicine (Vol. 48, pp. 101423-). https://doi.org/10.1016/j.eclinm.2022.101423
DOI: https://doi.org/10.1016/j.eclinm.2022.101423
SwePub: oai:prod.swepub.kib.ki.se:150119517

Carli, V., Wasserman, D., Hadlaczky, G., Petros, N. G., Carletto, S., Citi, L., ... & Scilingo, E. P. (2020). A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions. BMC psychiatry, 20(1), 1-10.
DOI: https://doi.org/10.1186/s12888-020-02494-3

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Published: 2023-05-25