An interventional study of Person-centred care at distance through an eHealth platform in Mental Health, sponsored by Göteborg University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Göteborg University · Not applicable, Interventional, and Supportive care
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Among 28 studies in Psychological Well-Being with a site in Sweden — 6 open to participants now, 10 under way, none of them phase 3. Psychological Well-Being · Sweden.
Among the 28 studies in Psychological Well-Being with a site in Sweden, this one is the 6th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2018, is one of 19 with no phase, and was the 6th registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →6 of the 28 studies in Psychological Well-Being with a site in Sweden are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in Sweden, United States, Australia and 2 more countries
Ages 12–99 · Healthy volunteers
Kristianstad University · Sites in Sweden
Ages 13–19 · Healthy volunteers
Linnaeus University · Sites in Sweden
Ages 6–10
Region Skane · Sites in Sweden
Ages 11–18
Uppsala University · Sites in Sweden
Ages 15–29 · Healthy volunteers
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
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28 studies; the count open now beside each. This study's row is marked.
First in 1916; this study’s year is marked. 4 started in 2018.
This study's planned enrollment of 220 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 134 across the 21 interventional studies, 3,000 across the 7 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
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1 of 28 have an industry lead sponsor. The 10 most frequent:
Göteborg University is the lead sponsor of 270 studies on the registry; 46 are open to participants now.
Göteborg University has 1 study filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
3 of the studies in Psychological Well-Being with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06490120Uppsala UniversityA Study on Young Individuals' Mental Health in Sweden | 2027-03-31 |
| NCT06594913University of North Carolina, Chapel HillEating Disorders Genetics Initiative 2 | 2027-09-01 |
| NCT07111676Region Örebro CountyEvaluation of the School-based SIM Program in Upper Secondary School Students | 2027-10 |
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Among the 28 studies in Psychological Well-Being with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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 1:1. 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 3,6,12,18 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 patient´s 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." 3."Support 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 capabilities/resources 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 he/she 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 patient´s 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Person-centred care at distance through an eHealth platform
Behavioral: Person-centred care at distance through an eHealth platform
Evidence-based care
Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives
Composite score of changes
A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 6 months reduced sick leave and increased general self-efficacy by ≥ 5 units A patient is classified as deteriorated if: at 6 months increased sick leave or (if on full-time sick leave at inclusion reduced general self-efficacy by ≥ 5 units) Those who have neither deteriorated nor improved are considered unchanged
Time frame: baseline, 3, 6, 12, 18, 24 months
Sick leave
Grade of sick leave
Time frame: baseline, 3, 6, 12, 18, 24 months
General self-efficacy scale
Questionnaire
Time frame: baseline, 3, 6, 12, 18, 24 months
Health-related quality of Life (EQ-5D)
Questionnaire
Time frame: baseline, 3, 6, 12, 18, 24 months
Hospital anxiety and depression scale (HADS)
Questionnaire
Time frame: baseline, 3, 6, 12, 18, 24 months
Symptom burden (Shirom-Melamed Burnout Measure)
Questionnaire
Time frame: baseline, 3, 6, 12, 18, 24 months
Perceived stress scale (PSS)
Questionnaire
Time frame: baseline, 3, 6, 12, 18, 24 months
Self-rated burnout syndrome (s-UMS)
Questionnaire
Time frame: baseline, 3, 6, 12, 18, 24 months
Health care utilization
Health care utilization
Time frame: 3, 6, 12, 18, 24 months
Incremental cost-utility ratios
Incremental cost-utility ratios
Time frame: 3, 6, 12, 18, 24 months
Multidimensional fatigue symptom inventory (MFI-20)
Questionnaire
Time frame: 3, 6, 12, 18, 24 months
Sheehan disability scale (SDS)
Questionnaire
Time frame: 3, 6, 12, 18, 24 months
Self-efficacy (self-care)
Questionnaire
Time frame: 3, 6, 12, 18, 24 months
Plan to share: No
Started Feb 2018 (actual). Primary completion is estimated for Jan 2021, 35 months after the start.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 35 months is above that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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