FrailtyIHOPeNCT04416815
Integrating Health Promotion With and for Older People - eHealth
A study testing Integrating Health promotion with and for Older People - eHealth in people with Frailty and Old Age, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- What is being tested?
- Integrating Health promotion with and for Older People - eHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Arvid Wallgrensbacke 7
Gothenburg, Gothenburg, 405 30
Inger Ekman, Professor, +46739815765, inger.ekman@gu.se
Zahra Ebrahimi, pHD, +46-766186025, zahra.ebrahimi@gu.se
About this study
Official title: Integrating Health Promotion With and for Older People - eHealth: a Randomised Controlled Trial, in the Context of Good Quality Local Health Care
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.
Read the 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.
- Being tested
- Integrating Health promotion with and for Older People - eHealth
- 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
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrating Health promotion with and for Older People - eHealthOther
The intervention will be delivered for 6 months on top of usual care. It will be provided by HCPs. If needed one home visit to install the digital platform will be conducted. A HCP will introduce how to use the digital platform and create a personal account. The intervention starts with a person-centred phone-call where a health plan is co-created and potential team members to support this are identified and invited. The health plan includes the older persons' goals, internal and external resources, and need of support from health and/or social-services. This plan will be the point of departure for the forthcoming dialogue. A digital platform will open up for extended and safe communication and visualize the health planning between the older person and team-members in different settings. The older person and the HCP and involved team members on the digital platform will regularly evaluate the health plan and commonly agreed goals.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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). |
| eHealth | Experimental | The intervention will be delivered for 6 months on top of usual care. Receives: Other: Integrating Health promotion with and for Older People - eHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of changes in general self-efficacy and need for hospital care
The primary outcome is a composite of changes in general self-efficacy and need for hospital care for unscheduled reasons. Each participant will be classified as improved, deteriorated or unchanged if at 3 months:
- Deteriorated: the participant's self-efficacy has decreased by ≥ 5 units (the minimal change of clinical significance), or the participant has been admitted to hospital for unscheduled reasons two times or more.
- Improved: general self-efficacy has increased by ≥ 5 units and the participant has been admitted to hospital no more than once.
- Unchanged: Neither deteriorated nor improved. (Questionnaire and medical record)
Measured: Baseline, 3
Secondary outcomes (9)
Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)
EQ5D is a generic measure of health status consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with responses indicating three levels of severity (no problems/some or moderate problems/extreme problems), the EQ Visual Analogue scale (EQ-VAS); a standard vertical 20 cm visual analogue scale for recording an individual's rating of their current health-related quality of life state raging from 'the best health you can imagine' to 'the worst health you can imagine'. (Questionnaire)
Measured: Baseline, 3, 6, 12 months
General Self Efficacy
General Self-Efficacy Scale (GSE scale) is a 10-item self-assessment questionnaire designed to measure a broad and stable sense of personal competence to deal effectively with a variety of stressful situations. Ratings are made on a 4-point scale (1 = not at all true, 2 = hardly true, 3 = moderately true, 4 = exactly true) and are summed to a total score ranging from 10 to 40, where higher scores indicate greater self-efficacy. (Questionnaire)
Measured: Baseline, 3, 6, 12 months
Hospitalization
The number of un-planned hospitalization. (Questionnaire and medical record)
Measured: Baseline, 3, 6, 12 months
ICEpop CAPability measure for Older people (ICECAP-O)
The ICECAP-O capability index estimate quality of life in a broader sense, including five attributes (attachment, role, enjoyment, security, and control), each with four levels of response. (Questionnaire)
Measured: Baseline, 3, 6, 12 months
A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons
A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons at 6 and 12 moths.
Measured: Baseline, 6, 12 months
Change in daily activities based on the ADL-staircase
Independence from, or dependence on, another person in daily activities will be assessed based the ADL-staircase. The ADL-staircase applies a cumulative scale of ten well-defined personal activities (P-ADLs: bathing, dressing, going to the toilet, transfer, continence and feeding) and instrumental activities (I-ADLs: cleaning, shopping, transportation and cooking). Dependence is defined as receiving personal or directive assistance from another person. Participants living with another person is assessed as "independent" if they are capable of performing the activity independently. (Questionnaire)
Measured: Baseline, 3, 6, 12 months
Societal costs
Resource use included in the economic evaluation will include: healthcare use (Region Västra Götaland), drug use and social care (National Board of Health and Welfare), as well as costs for informal care and other costs to the individual and/or family and friends related to the treatment collected from patient questionnaires and diaries. Costs (both reimbursements and out of pocket costs) for prescribed medications will be obtained from the Swedish Prescribed Drug Register. Cost per patient for healthcare use will be obtained from the register, and in resource use not recorded costs will be derived using national statistics, as will costs for social care and other costs reported in questionnaires. Informal care costs will be viewed as directs costs, and thus valued at the average wage and social security contribution of employing a formal caregiver.
Measured: Baseline, 3, 6, 12 months
Incremental cost-effectiveness Ratio (ICER)
The ICER will be calculated as the difference in costs, between groups, divided by the corresponding difference in quality-adjusted life years (QALY). For the main analysis, QALYs will be derived from the EQ-5D index using the Swedish experience-based value set and using an area-under-the-curve calculation. Sensitivity analyses will be conducted using a society-based value set and the economic evaluation will also be conducted using a corresponding method with ICECAP-O as the health outcome.(Questionnaire)
Measured: Baseline, 3, 6, 12 months
Change in number of fall
Self-reported number of fall during the last three months (Questionnaire)
Measured: Baseline, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start25 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416815
- Sponsor's protocol ID
- GoteborgU-GPCC-IHOPe
- Acronym
- IHOPe
- Status last verified
- Mar 2025
- First submitted
- 2 Apr 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15031310Social 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.
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.
PubMed 12801252Bandura 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.
PubMed 847061Fors 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.
PubMed 25149667Ekman 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.
PubMed 21764386May 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.
PubMed 17650326Craig 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.
PubMed 18824488Grewal 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.
PubMed 16168542Schultz-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.
PubMed 17095107Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PubMed 10158943Schwarzer, 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.
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.
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.
PubMed 8869511Gustafsson 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.
PubMed 30596153
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Health Promotion With and for Older People - eHealth: a Randomised Controlled Trial, in the Context of Good Quality Local Health Care
- ClinicalTrials.gov ID
- NCT04416815
- Acronym / sponsor ID
- IHOPe / GoteborgU-GPCC-IHOPe
- Keywords
- Person-centredness, Telemedicine, RCT, e-health, Process Evaluation, Health Economic Evaluation, Health Plan, Partnership
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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). |
| eHealth | Experimental | Other: Integrating Health promotion with and for Older People - eHealthThe intervention will be delivered for 6 months on top of usual care. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrating Health promotion with and for Older People - eHealthThe intervention will be delivered for 6 months on top of usual care. It will be provided by HCPs. If needed one home visit to install the digital platform will be conducted. A HCP will introduce how to use the digital platform and create a personal account. The intervention starts with a person-centred phone-call where a health plan is co-created and potential team members to support this are identified and invited. The health plan includes the older persons' goals, internal and external resources, and need of support from health and/or social-services. This plan will be the point of departure for the forthcoming dialogue. A digital platform will open up for extended and safe communication and visualize the health planning between the older person and team-members in different settings. The older person and the HCP and involved team members on the digital platform will regularly evaluate the health plan and commonly agreed goals. | Other | eHealth |
Primary outcome
A composite of changes in general self-efficacy and need for hospital care
Time frame: Baseline, 3
The primary outcome is a composite of changes in general self-efficacy and need for hospital care for unscheduled reasons. Each participant will be classified as improved, deteriorated or unchanged if at 3 months: * Deteriorated: the participant's self-efficacy has decreased by ≥ 5 units (the minimal change of clinical significance), or the participant has been admitted to hospital for unscheduled reasons two times or more. * Improved: general self-efficacy has increased by ≥ 5 units and the participant has been admitted to hospital no more than once. * Unchanged: Neither deteriorated nor improved. (Questionnaire and medical record)
9 secondary outcomes
Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)
Time frame: Baseline, 3, 6, 12 months
General Self Efficacy
Time frame: Baseline, 3, 6, 12 months
Hospitalization
Time frame: Baseline, 3, 6, 12 months
ICEpop CAPability measure for Older people (ICECAP-O)
Time frame: Baseline, 3, 6, 12 months
A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons
Time frame: Baseline, 6, 12 months
Change in daily activities based on the ADL-staircase
Time frame: Baseline, 3, 6, 12 months
Societal costs
Time frame: Baseline, 3, 6, 12 months
Incremental cost-effectiveness Ratio (ICER)
Time frame: Baseline, 3, 6, 12 months
Change in number of fall
Time frame: Baseline, 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 15031310Fried 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.
- BackgroundSocial 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.
- Background: PubMed 12801252McCormack 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.
- Background: PubMed 847061Bandura 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.
- Background: PubMed 25149667Fors 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.
- Background: PubMed 21764386Ekman 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.
- Background: PubMed 17650326May 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.
- Background: PubMed 18824488Craig 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.
- Background: PubMed 16168542Grewal 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.
- Background: PubMed 17095107Schultz-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.
- Background: PubMed 10158943Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
- BackgroundSchwarzer, 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.
- Study ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrating Health promotion with and for Older People - eHealth in people with Frailty and Old Age, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of changes in general self-efficacy and need for hospital care (time frame: Baseline, 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416815, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.