Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Frailty
  • Old Age
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: RCT: All older people who give consent for participation and who fulfill the inclusion criteria will be randomised. Randomisation will be conducted by research nurses. Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per a computer generated randomisation. The control group will receive usual care. The intervention group will receive person-centred care intervention during 6 month on top of usual care.Masking: None (Open Label)Masking Description: The nature of the intervention means that neither participants nor the health care professionals (HCP) in the IHOPe intervention can be blinded to allocation in the RCT.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 75 years and 125 years
Gender
Both males and females

Description

Background: Healthcare systems worldwide are not equipped to accommodate for the growing population of older people. In Sweden alone the proportion of people aged 65 years and older is estimated to increase to 23% by 2030. Furthermore, the number of people aged over 80 years in 2017 exceeded 500 000...

Background: Healthcare systems worldwide are not equipped to accommodate for the growing population of older people. In Sweden alone the proportion of people aged 65 years and older is estimated to increase to 23% by 2030. Furthermore, the number of people aged over 80 years in 2017 exceeded 500 000 and is expected to increase by around 50% by 2027. People in this age group often have an increased risk for developing frailty, multi-morbidity and functional impairments. Thus, there is an urgent call for innovative approaches to both promote health and to design a sustainable healthcare system that is accessible, resource effective and enables health in frail older people. Person-centered care (PCC) and digital health services are considered keystones in such a healthcare system redesign, and may enable efficient and resource effective teamwork that strengthens a preventive approach and promotes older people's self-efficacy. Previous and ongoing studies show that PCC can be delivered at a distance, but needs to be further developed from a teamwork aspect. Therefore, the IHOPe project focuses on integrating health promotion with and for frail older people by working as a team via a digital platform. To the best of our knowledge, no previous research has investigated the effectiveness of initiating health planning with and for frail older people through a PCC telephone support and eHealth intervention where patients are able to create a personal team by inviting informal and formal carers from both health and social care services into their health team if needed. The overall aim is to describe and evaluate a person-centered eHealth intervention that promotes a sustainable partnership between community-dwelling frail older people and health and social care professionals. Design: The IHOPe trial is designed as a randomized, controlled, trial with two parallel groups and a primary endpoint 6 month after inclusion. Randomization will be performed through computer generated lists with a 1:1 allocation. In addition, the IHOPe project includes a pilot and feasibility study, a health economic evaluation and a process evaluation. The project is a complex intervention and as such features a multitude of influencing factors. The study design was guided by the revised Medical Research Council's (MRC) framework for complex interventions. The IHOPe project consists of two phases: Phase 1: Develop and test feasibility of a person-centered eHealth intervention and pilot the RCT design. Phase 2: Evaluate the effects, describe the process and perform a health economic evaluation of the person-centered eHealth intervention. Studysetting/Context: The IHOPe project is conducted in a middle sized city in Sweden and targets community dwelling older people, their family and friends and professionals working in local social and health care services. The intervention is delivered in an eHealth context and is coordinated by designated research nurses. In Sweden there is an ongoing redesign of health care services towards good quality local health care [nära vård], which aims to strengthen primary care services and self-care. Health care costs in medical care are mainly financed through taxes and municipalities are responsible for services for older persons according to assessed needs. There are a number of actors representing different organizations involved in health and social care targeting older people. In addition, to such municipal services there are also private health and social care providers. It is also common that older people are receiving support or help from significant others. Participants and recruitment procedure: Participants will be recruited from either an emergency department or a primary care center in the western region of Sweden. Potential participants will be screened against inclusion and exclusion criteria for eligibility. Frailty screening will be performed by research assistants employed in the project at the emergency department or a primary care center if possible or otherwise by phone. The FRESH screening tool will be used which includes four short questions. If the answer is yes on two or more of these four questions patients is applicable for inclusion in the study. A Study Information letter and invitation to participate will be sent to eligible patients. After informed consent participants will be randomized to the intervention- or the control group. Study population: The RCT, targets frail older people aged 75 years or older living in ordinary housing. The feasibility study and process evaluation also include significant others and carers that are invited to the IHOPe platform. Control group/usual care: The participants allocated to the control group received no intervention. However, they could, on their own initiative, approach the usual range of community or health services (e.g., home help services, rehabilitation, or medical care). Intervention/The eHealth support: The IHOPe intervention is provided in addition to usual care for six months. It comprises an agreed upon number of person-centered phone calls (stimulating narration) and co-creation of care through a digital platform. The intervention aims to initiate partnership-building and to promote older people to identify and use their own capabilities and resources such as strong will, social relations, etc. During the intervention goals will be formulated and set in partnership to promote self-efficacy and the ability to cope with frailty in daily life. The older person (at times in collaboration with significant others) will together with a dedicated health care professional (HCP) formulate a person-centered health plan, which is then uploaded to the IHOPe platform. The health plan will focus on the older persons' goals, resources and needs, and experienced need of support from health and/or social care as well as family and friends to reach the goals. Depending on agreements during the phone-call family and friends and additional health or social care professionals may be invited to teamwork on the IHOPe platform. The health plan will be the point of departure for the forthcoming dialogue. IHOPe is provided in an eHealth context by designated HCPs trained in delivering PCC at a distance. Throughout the study, the HCP and patient (and team) will communicate to regularly evaluate the health plan and any need to reformulate the goals. The intervention is provided at a distance. If needed one home visit to install the digital platform (via the participant's smart tablet, smartphone or computer) will be conducted. A health professional will introduce how to use the digital platform and create a personal account.

Tracking Information

NCT #
NCT04416815
Collaborators
Not Provided
Investigators
Study Chair: Inger Ekman University of Gothenburg, Institute of health and caring scineces