NCT04416815

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Jan 2021Dec 2027

First Submitted

Initial submission to the registry

April 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

4.9 years

First QC Date

April 2, 2020

Last Update Submit

March 11, 2025

Conditions

Keywords

Person-centrednessTelemedicineRCTe-healthProcess EvaluationHealth Economic EvaluationHealth PlanPartnershipFrailtyElderlyPerson-centred carePatient-centred carePerson-centered carePatient-centered careIntegrated careHealth promotioneHealth

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline, 3

Secondary Outcomes (9)

  • Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)

    Baseline, 3, 6, 12 months

  • General Self Efficacy

    Baseline, 3, 6, 12 months

  • Hospitalization

    Baseline, 3, 6, 12 months

  • ICEpop CAPability measure for Older people (ICECAP-O)

    Baseline, 3, 6, 12 months

  • A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons

    Baseline, 6, 12 months

  • +4 more secondary outcomes

Other Outcomes (2)

  • Change in burden of medicines use in everyday life based on The Living with medicines questionnaire version 3 (LMQ-3)

    Baseline, 3, 6, 12 months

  • Change in the participants' self-rated overall level of medicines burden

    Baseline, 3, 6, 12 months

Study Arms (2)

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.

Other: Integrating Health promotion with and for Older People - eHealth

Interventions

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.

eHealth

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arvid Wallgrensbacke 7

Gothenburg, Gothenburg, 405 30, Sweden

RECRUITING

Related Publications (20)

  • 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.

    PMID: 15031310BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12801252BACKGROUND
  • 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.

    PMID: 847061BACKGROUND
  • 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.

    PMID: 25149667BACKGROUND
  • 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.

    PMID: 21764386BACKGROUND
  • 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.

    PMID: 17650326BACKGROUND
  • 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.

    PMID: 18824488BACKGROUND
  • 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.

    PMID: 16168542BACKGROUND
  • 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.

    PMID: 17095107BACKGROUND
  • Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.

    PMID: 10158943BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 8869511BACKGROUND
  • 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.

    PMID: 30596153BACKGROUND
  • Åsberg-Hulter, K., ADL-trappan (ADL- Staircase). 1990, Lund: Studentlitteratur.

    BACKGROUND
  • 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.

    PMID: 16129869BACKGROUND
  • 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.

    PMID: 29881317BACKGROUND
  • 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.

    PMID: 36973667BACKGROUND
  • Ebrahimi Z, Olaya-Contreras P, Goudarzi M, Ekman I. Experiences of a remote, person-centred intervention in older persons living with frailty - a qualitative study. BMC Geriatr. 2025 Oct 15;25(1):779. doi: 10.1186/s12877-025-06509-0.

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

June 4, 2020

Study Start

January 25, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations