Clinical trial NCT04416815: Integrating Health Promotion With and for Older People - eHealth
Official title: Integrating Health Promotion With and for Older People - eHealth: a Randomised Controlled Trial, in the Context of Good Quality Local Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Old Age
Keywords: Person-centredness
Telemedicine
RCT
e-health
Process Evaluation
Health Economic Evaluation
Health Plan
Partnership
Frailty
Elderly
Person-centred care
Patient-centred care
Person-centered care
Patient-centered care
Integrated care
Health promotion
eHealth
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2020-06-04
Enrollment: 220
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Integrating Health promotion with and for Older People eHealth (IHOPe) project is expected to contribute vital knowledge on how older peoples capabilities and societal resources can be used in a more efficient way to promote health, self-management and enhance teamwork in partnership.The aim is to describe and evaluate this person-centered e-support intervention that promotes a sustainable partnership between community-dwelling frail older people and health and social care professionals. A digital platform, co-created with users and designed to create inclusion of individuals who today are living in a digital alienation, will be used in the health planning. In IHOPe frail older people will be able to identify their potential health issues but also their resources together with team partners from health- and social care, family or societal representatives. The intervention consists of person-centered phone calls with a health care professional as well as access to a digital platform that is accessible to the old person and invited team-partners. The project includes a randomized controlled trial, a process evaluation and a health economic evaluation. People 75 years or older screened as frail will be included. Also, in the process evaluation team-partners using the digital platform will be included. Specifically, this project is expected to reduce hospitalizations, result in improved or retained self-efficacy whilst being cost effective. Additionally, the project is expected to enhance frail older peoples opportunities to participate as an equal partner in their contacts with health and social services.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* National registration within the Västra Götalands region (VGR), community dwelling people (men and women) aged 75 and older living in ordinary housing, and screened as frail at a primary care center or the emergency department but not hospitalized.

Exclusion Criteria:

* In need of palliative care in the final stages of life, no registered address, participating in any other conflicting randomised study, or cognitive dysfunctional (not oriented to time, place and person).

Primary outcomes:
measure: A composite of changes in general self-efficacy and need for hospital care
timeFrame: Baseline, 3
Secondary outcomes:
measure: Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)
timeFrame: Baseline, 3, 6, 12 months
measure: General Self Efficacy
timeFrame: Baseline, 3, 6, 12 months
measure: Hospitalization
timeFrame: Baseline, 3, 6, 12 months
measure: ICEpop CAPability measure for Older people (ICECAP-O)
timeFrame: Baseline, 3, 6, 12 months
measure: A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons
timeFrame: Baseline, 6, 12 months
measure: Change in daily activities based on the ADL-staircase
timeFrame: Baseline, 3, 6, 12 months
measure: Societal costs
timeFrame: Baseline, 3, 6, 12 months
measure: Incremental cost-effectiveness Ratio (ICER)
timeFrame: Baseline, 3, 6, 12 months
measure: Change in number of fall
timeFrame: Baseline, 3, 6, 12 months
Other outcomes:
measure: Change in burden of medicines use in everyday life based on The Living with medicines questionnaire version 3 (LMQ-3)
timeFrame: Baseline, 3, 6, 12 months
measure: Change in the participants' self-rated overall level of medicines burden
timeFrame: Baseline, 3, 6, 12 months
Locations:
city: Göteborg
country: Sweden
facility: Arvid Wallgrensbacke 7
state: Gothenburg
Study officials:
References:
citation: Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
citation: Social Board. Being able to follow the patient's path through care Ways to link care events in the patient care process (Att kunna följa patientens väg genom vården Sätt att koppla samman vårdhändelser i patientens vårdprocess) socialstyrelsen, Editor. 2019, www.Socialstyrelsen.se, februari 2019 Stockholm.
citation: McCormack B. A conceptual framework for person-centred practice with older people. Int J Nurs Pract. 2003 Jun;9(3):202-9. doi: 10.1046/j.1440-172x.2003.00423.x.
citation: Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
citation: Fors A, Ulin K, Cliffordson C, Ekman I, Brink E. The Cardiac Self-Efficacy Scale, a useful tool with potential to evaluate person-centred care. Eur J Cardiovasc Nurs. 2015 Dec;14(6):536-43. doi: 10.1177/1474515114548622. Epub 2014 Aug 22.
citation: Ekman I, Swedberg K, Taft C, Lindseth A, Norberg A, Brink E, Carlsson J, Dahlin-Ivanoff S, Johansson IL, Kjellgren K, Liden E, Ohlen J, Olsson LE, Rosen H, Rydmark M, Sunnerhagen KS. Person-centered care--ready for prime time. Eur J Cardiovasc Nurs. 2011 Dec;10(4):248-51. doi: 10.1016/j.ejcnurse.2011.06.008. Epub 2011 Jul 20.
citation: May CR, Mair FS, Dowrick CF, Finch TL. Process evaluation for complex interventions in primary care: understanding trials using the normalization process model. BMC Fam Pract. 2007 Jul 24;8:42. doi: 10.1186/1471-2296-8-42.
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
citation: Grewal I, Lewis J, Flynn T, Brown J, Bond J, Coast J. Developing attributes for a generic quality of life measure for older people: preferences or capabilities? Soc Sci Med. 2006 Apr;62(8):1891-901. doi: 10.1016/j.socscimed.2005.08.023. Epub 2005 Sep 15.
citation: Schultz-Larsen K, Avlund K. Tiredness in daily activities: a subjective measure for the identification of frailty among non-disabled community-living older adults. Arch Gerontol Geriatr. 2007 Jan-Feb;44(1):83-93. doi: 10.1016/j.archger.2006.03.005. Epub 2006 Nov 13.
citation: Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
citation: Schwarzer, R, Jerusalem, M, Generalized Self-Efficacy scale. In: Weinman J, Wright S, & Johnston M, eds. Measures in health psychology: A user's portfolio Causal and control beliefs. Windsor, England. NFER-NELSON 1995. pp. 35-37.
citation: Horder H, Gustafsson, S, Rydberg T, Skoog I, Waern M. A Cross-Cultural Adaptation of the ICECAP-O: Test-Retest Reliability and Item Relevance in Swedish 70-Year-Olds. Societies 2016. 6(4): p. 30.
citation: Sonn U, Grimby G, Svanborg A. Activities of daily living studied longitudinally between 70 and 76 years of age. Disabil Rehabil. 1996 Feb;18(2):91-100. doi: 10.3109/09638289609166023.
citation: Gustafsson S, Horder H, Hammar IO, Skoog I. Face and content validity and acceptability of the Swedish ICECAP-O capability measure: Cognitive interviews with 70-year-old persons. Health Psychol Res. 2018 May 8;6(1):6496. doi: 10.4081/hpr.2018.6496. eCollection 2018 May 8.
citation: Åsberg-Hulter, K., ADL-trappan (ADL- Staircase). 1990, Lund: Studentlitteratur.
citation: Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
citation: Katusiime B, Corlett SA, Krska J. Development and validation of a revised instrument to measure burden of long-term medicines use: the Living with Medicines Questionnaire version 3. Patient Relat Outcome Meas. 2018 May 28;9:155-168. doi: 10.2147/PROM.S151143. eCollection 2018.
citation: Ebrahimi Z, Barenfeld E, Gyllensten H, Olaya-Contreras P, Fors A, Fredholm E, Fuller JM, Godarzi M, Krantz B, Swedberg K, Ekman I. Integrating health promotion with and for older people - eHealth (IHOPe) - evaluating remote integrated person-centred care : Protocol of a randomised controlled trial with effectiveness, health economic, and process evaluation. BMC Geriatr. 2023 Mar 27;23(1):174. doi: 10.1186/s12877-023-03866-6.