Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03404583
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2018-01-12
Brief Title:
Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome - a Randomized Controlled Trial in Primary Health Care
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief Summary:
The goal of the research project PROMISE is to translate the person-centred care PCC principles into an eHealth the use of information and communication technologies for health context A developed PCC eHealth platform will be used as a tool to identify patients resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives The PCC eHealth platform will not replace but instead be used as add on treatment to usual care guideline directed care
Detailed Description:
A pilot study and collaboration between patients relatives and professionals in the research program has clarified the need to develop a PCC eHealth platform Previous research has shown that eHealth support where the users are not involved in the process has a low impact and has highlighted several limitations with respect to patients participation in the design process its anchorage in the home and local environment and opportunities for communication rather than information Therefore this study has a participatory design which assumes that all users patients relatives and health care professionals are involved in the study design which facilitates implementation An end-user perspective as a starting point increases the chances that users adapt a positive attitude towards the new system Person-centred care combined with an eHealth support along the chain of health care showed a 4-fold chance of improved self-efficacy in combination with return to work or prior activity level after an event of acute coronary syndrome
The aim of this project is that PCC can be delivered at distance and make health care more effective above and beyond usual care Inclusion of the principles of PCC in an eHealth support for patients with stress depression or anxiety will improve return to work rates reduced relapse reduce costs and improved self-efficacy
In the PCC approach the aims capabilities and needs of each patient will be the starting point Self-care strategies will be reinforced and empowered
This study is a randomized open parallel group intervention study where patients are eligible when they start their sick leave period due to stress depression or anxiety They will be asked about participation after being diagnosed and their sick leave has been approved
Patients will be randomized into either the control or the intervention arm 11 The control group will receive usual care The intervention group will receive usual care plus a PCC intervention through an eHealth platform Randomization will be done through computer generated lists and stored in sealed envelopes
Patients listed in primary care with a confirmed diagnosis of stress depression or anxiety will be screened and sent an informing letter about the study from the chief at each centre Specially trained registered nurses RNs will then screen patients against study inclusion and exclusion criteria and by phone contact eligible patients and inform the patient about the aims of the study and ask if they are interested to participate If the patient wants to participate a consent form is sent to the patient and then returned to the RN Written informed consent will then be obtained Then the randomization procedure is performed which is stratified for age 50y and diagnosis stress depression and anxiety and the patient will be informed about the outcome by phone Patients randomized to the intervention group will need a computer smart phone or iPad to participate in the study
Two dedicated full-time RNs follow the procedures closely A monitor controls the protocol adherence All case record forms questionnaires and referrals will be constructed for intervention and usual care groups
Follow-up questionnaires on general self-efficacy self-efficacy self-care quality of life anxiety and depression symptom burden and daily functional level will be sent out to all patients in both groups after 361218 and 24 months after randomization
Patients randomized to usual care will be managed by regular evidence-based treatment and care as outlined in treatment guidelines and followed as usual at their local primary care centre
Patients will be contacted by a RN who has received special training in PCC communication at distance through the eHealth platform for an initial person-centred dialogue by phone Based on the patient narrative patients goals resources and needs are identified The patient sometimes maybe together with relatives and the RN formulate a person-centred health plan This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about stress depression and anxiety The plan will be the point of departure for the forthcoming dialogue at distance via the eHealth platform that the patient and the RN will have during the study period 6 months
The eHealth support contains headings that may inspire the patient to make notes on a good day respectively a bad day and register daily health related status The health plan contain three parts 1 My goal is to feel or be able to do 2 To be able to reach my goal I will 3Support I need to reach my goal In the communication during the study period between the RN and patient the personal health plan is discussed and any needs of reformulating the goals may be discussed The overall goal is to help the patient to identify their own capabilitiesresources such as a strong will social relations etc and formulate goals that help them increase their self-efficacy and to cope with their condition in daily life
The RN presents the eHealth support for communication computer iPad smart phone and they agree on how they will be in contact thereafter The RN invites the patient and activates their account where heshe can login via an individual user name and formulate comment evaluate or develop the health plan Access to the diary will be password protected The RN can see the patients account and make comments The patient can add or delete staff or private persons that have access to the account and the patient can also limit the access for each user invited
The aim of this project is that PCC can be delivered at distance and make health care more effective above and beyond usual care Inclusion of the principles of PCC in an eHealth support for patients with stress depression or anxiety will improve return to work rates reduced relapse reduce costs and improved self-efficacy
In the PCC approach the aims capabilities and needs of each patient will be the starting point Self-care strategies will be reinforced and empowered
This study is a randomized open parallel group intervention study where patients are eligible when they start their sick leave period due to stress depression or anxiety They will be asked about participation after being diagnosed and their sick leave has been approved
Patients will be randomized into either the control or the intervention arm 11 The control group will receive usual care The intervention group will receive usual care plus a PCC intervention through an eHealth platform Randomization will be done through computer generated lists and stored in sealed envelopes
Patients listed in primary care with a confirmed diagnosis of stress depression or anxiety will be screened and sent an informing letter about the study from the chief at each centre Specially trained registered nurses RNs will then screen patients against study inclusion and exclusion criteria and by phone contact eligible patients and inform the patient about the aims of the study and ask if they are interested to participate If the patient wants to participate a consent form is sent to the patient and then returned to the RN Written informed consent will then be obtained Then the randomization procedure is performed which is stratified for age 50y and diagnosis stress depression and anxiety and the patient will be informed about the outcome by phone Patients randomized to the intervention group will need a computer smart phone or iPad to participate in the study
Two dedicated full-time RNs follow the procedures closely A monitor controls the protocol adherence All case record forms questionnaires and referrals will be constructed for intervention and usual care groups
Follow-up questionnaires on general self-efficacy self-efficacy self-care quality of life anxiety and depression symptom burden and daily functional level will be sent out to all patients in both groups after 361218 and 24 months after randomization
Patients randomized to usual care will be managed by regular evidence-based treatment and care as outlined in treatment guidelines and followed as usual at their local primary care centre
Patients will be contacted by a RN who has received special training in PCC communication at distance through the eHealth platform for an initial person-centred dialogue by phone Based on the patient narrative patients goals resources and needs are identified The patient sometimes maybe together with relatives and the RN formulate a person-centred health plan This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about stress depression and anxiety The plan will be the point of departure for the forthcoming dialogue at distance via the eHealth platform that the patient and the RN will have during the study period 6 months
The eHealth support contains headings that may inspire the patient to make notes on a good day respectively a bad day and register daily health related status The health plan contain three parts 1 My goal is to feel or be able to do 2 To be able to reach my goal I will 3Support I need to reach my goal In the communication during the study period between the RN and patient the personal health plan is discussed and any needs of reformulating the goals may be discussed The overall goal is to help the patient to identify their own capabilitiesresources such as a strong will social relations etc and formulate goals that help them increase their self-efficacy and to cope with their condition in daily life
The RN presents the eHealth support for communication computer iPad smart phone and they agree on how they will be in contact thereafter The RN invites the patient and activates their account where heshe can login via an individual user name and formulate comment evaluate or develop the health plan Access to the diary will be password protected The RN can see the patients account and make comments The patient can add or delete staff or private persons that have access to the account and the patient can also limit the access for each user invited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None