NCT04955600

Brief Summary

In this study, the objective is to evaluate available technology designed to support self-care at home of elderly patients with multimorbidity. Of people who are 85 years or older, about 60% have two or more chronic diseases. The symptom burden is extensive, and periods of deterioration often lead to hospitalizations and early readmissions to hospital. A contributing factor for the high consumption of care is that many patients find it difficult to identify signs of deterioration and in time take appropriate action. Technology placed in patients' home are becoming common and have shown to increase quality of life and reduce the need for in-hospital care but few tools are used in regular care. The investigators want to see which effect technologies placed at home has on; healthcare consumption, self-care, depression, well-being and activity level. Further, the implementation process from both patients, relatives and healthcare personals perspective will be studied using a hybrid design, which makes it possible to study both barriers and facilitators of the implementation and efficacy of the technology. In phase one participants will be recruited from a care team where an established collaboration between region and municipality has been developed. In phase two, inclusion takes place in an entire municipality without a previously established collaboration. The goal is to increase patients and family members wellbeing, health and functional ability while maintaining or reducing healthcare costs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

June 16, 2021

Last Update Submit

April 3, 2024

Conditions

Keywords

telemonitoringdistance monitoringfeasibilityimplementationelderly

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of digital technology

    Healthcare consumption will be performed via regions healthcare database.

    December 2021-December 2022

  • Implementation process

    Healthcare professionals will be asked about potential barriers and facilitators for implementation of the technology, problems associated with the implementation, potential modifications that could be made to maximize implementation, potential implementation strategies, skills or training necessary for healthcare professionals to work with the technology.

    April 2021-December 2021

Secondary Outcomes (5)

  • Experience of digital technology

    December 2021-December 2022

  • Anxiety and depression

    December 2021-December 2022

  • Perceived control

    December 2021-December 2022

  • Well-being

    December 2021-December 2022

  • Physical activity

    December 2021-December 2022

Study Arms (1)

elderly patients with multimorbidity, relatives, health care personal

The care team consists of four nurses, two of whom are employed by the region and two by the municipality, 20 municipally employed assistant nurses and one physician. Other professions associated with the team are psychologist, dietitian, pharmacist, counsellor, physiotherapist, occupational therapist, and family consultants. All participants in the team will be invited to participate in the study. The technology will be place in 20-25 patients' home and patients and family members will be invited to participate in the study. Self-care education will be given to the patients and family members according to the middle-range theory of self-care of chronic illness.

Other: Implementation Study

Interventions

Implementation of digital technology in two different care settings from both patients, informal caregivers, and healthcare professional's perspective.

elderly patients with multimorbidity, relatives, health care personal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study aims to include all patients, family members and healthcare personal who is involved in the process of implementation of digital technology.

You may qualify if:

  • All patients admitted in the care team and their family members who will have digital technology placed in their home will be asked to participate.
  • All healthcare personal in the care team will be asked to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Care team in Region of Sörmland

Eskilstuna, SE-63188, Sweden

Location

Related Publications (1)

  • Liljeroos M, Arkkukangas M, Stromberg A. The long-term effect of an m-health tool on self-care in patients with heart failure: a pre-post interventional study with a mixed-method analysis. Eur J Cardiovasc Nurs. 2024 Jul 19;23(5):470-477. doi: 10.1093/eurjcn/zvad107.

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 9, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations