NCT05264207

Brief Summary

BACKGROUND The concurrence of multiple chronic conditions in older adults is associated with increased healthcare expenditure, increased hospital admissions, consultations and pharmaceutical expenditure. Having been diagnosed with multiple chronic conditions is associated with biopsychosocial health deterioration, worsening quality of life and increased mortality in older adults. Consequently, older adults with multiple chronic conditions present complex health statuses that require healthcare professional to focus on promoting health and independence through self-care. Available evidence suggests that the implementation of programs with individualized interventions focused on health promotion could improve self-care and other related variables in older people with chronic conditions. In this regard, the World Health Organization recommends the implementation of community health promotion programs including at least 5 home-visits carried out by healthcare professionals to promote self-care, independence, and quality of life amongst older adults with chronic conditions. However, the evidence on the cost-effectiveness of such visiting programs is inconsistent, which makes it difficult to integrate them into the services offered by public-funded healthcare systems. In search of more effective interventions to improve self-care and other related variables amongst older adults with multiple chronic conditions, nursing student visits could be a valid, effective alternative. Some studies suggest that the implementation of periodic follow-up programs (visits or telephone calls) by nursing students not only improves their knowledge and attitudes in relation to the care of older adults, but they could also have a positive impact on patients. STUDY'S HYPOTHESIS A program of supervised visits carried out by nursing students will significantly improve self-care behaviors and other related variables amongst older adults with multiple chronic conditions. AIM The aim of the VISITAME project is to examine the short-term (12 weeks) and medium-term (6 months) effects of a nursing students' home-visit programme on self-care behaviors amongst older adults with multiple chronic conditions. STUDY DESIGN A parallel two-arm randomized controlled trial (RCT) will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

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

First Submitted

Initial submission to the registry

February 14, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

February 14, 2022

Last Update Submit

December 19, 2023

Conditions

Keywords

chronic diseaseolder adultself-carehome-visitnursing student

Outcome Measures

Primary Outcomes (1)

  • Change in self-care behaviours

    Self-care in chronic illness inventory (SC-CII). The SC-CII will be used to measure the primary outcome of the study: 'self-care behaviours'. The SC-CII is a self-administered inventory, comprised of 20 items divided into 3 scales. The self-care maintenance scale is comprised of 8 items that measure, on a five-point Likert scale (1=never, 5=always), the frequency with which patients perform health-maintenance behaviors. The self-care monitoring scale is comprised of 5 items that measure, on a five-point Likert scale (1=never, 5=always), the frequency with which patients perform health-monitoring behaviors. The 'self-care management' scale is comprised of 7 items that measure, on a five-point Likert scale (1=not at all likely, 5=very likely), the probability for a patient to perform health-management behaviors. The scores of the three tools are calculated individually (between 0 and 100). Higher scores are indicative of better self-care.

    Changes from baseline to 3-month and 6-month follow-up

Secondary Outcomes (12)

  • Change in self-efficacy in self-care

    Changes from baseline to 3-month and 6-month follow-up

  • Change in loneliness

    Changes from baseline to 3-month and 6-month follow-up

  • Change in perceived social support

    Changes from baseline to 3-month and 6-month follow-up

  • Change in funcional capacity for activities of daily living

    Changes from baseline to 3-month and 6-month follow-up

  • Change in nutritional status

    Changes from baseline to 3-month and 6-month follow-up

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants allocated to the 'intervention group' arm will receive the usual care offered by the Public Andalusian Healthcare Service in conjunction with a 12-week nursing students' home-visit programme.

Behavioral: Nursing students' home-visit programmeBehavioral: Standard care from Public Andalusian Health Service

Control group

ACTIVE COMPARATOR

Participants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks.

Behavioral: Standard care from Public Andalusian Health Service

Interventions

12-week home-visit program conducted by nursing students. Participants will receive weekly 45-minute visits. The visits will aim to promote self-care behaviours and will focus on: 1. Self-care of chronic conditions and medication management 2. Healthy habits: physical activity and healthy eating 3. Access to social support resources 4. Patients' rights and autonomous decision-making The visits program will follow the WHO recommendations for the implementation of health promotion activities. All topics will be assigned 3 visits. In the first visit, the students will assess the participants' information needs and preferences in relation to the topic addressed and will provide generic information about it. In the second visit, the students will present individually-tailored information and will use individually-adapted strategies to convey such information. In the third visit, the student will explore the impact of the two previous visits and reinforce self-care behaviours.

Intervention group

Standard care offered by the Public Andalusian Health Service in its portfolio of services for older adults with multiple chronic conditions and complex health conditions. As part of these services, older adults with multiple chronic conditions receive generic, written information on healthy eating, adapted physical activity, abandonment of toxic habits, environmental safety and emotional management when they are first diagnosed with a chronic condition. The action plans or protocols established in the care processes aimed at older people with chronic multimnorbidity do not include periodic home visits.

Control groupIntervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years.
  • Having been diagnosed with more than one chronic condition.
  • Living at home (community-dwelling).
  • Signing the informed consent to participate in the study.

You may not qualify if:

  • Having cognitive impairment (Pfeiffer test \> 2 failures).
  • Having been diagnosed with a psychiatric condition (for example: schizophrenia).
  • Being a beneficiary of any of the services offered by the Fund of the Spanish National System for Autonomy and Support for Dependency.
  • Being a beneficiary of private personal assistance to help with functional dependency.
  • Participate in a program of similar nature from any public or private entities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Almería

Almería, 04120, Spain

Location

Related Publications (64)

  • Foguet-Boreu Q, Violan C, Rodriguez-Blanco T, Roso-Llorach A, Pons-Vigues M, Pujol-Ribera E, Cossio Gil Y, Valderas JM. Multimorbidity Patterns in Elderly Primary Health Care Patients in a South Mediterranean European Region: A Cluster Analysis. PLoS One. 2015 Nov 2;10(11):e0141155. doi: 10.1371/journal.pone.0141155. eCollection 2015.

    PMID: 26524599BACKGROUND
  • Garin N, Olaya B, Perales J, Moneta MV, Miret M, Ayuso-Mateos JL, Haro JM. Multimorbidity patterns in a national representative sample of the Spanish adult population. PLoS One. 2014 Jan 20;9(1):e84794. doi: 10.1371/journal.pone.0084794. eCollection 2014.

    PMID: 24465433BACKGROUND
  • Palladino R, Tayu Lee J, Ashworth M, Triassi M, Millett C. Associations between multimorbidity, healthcare utilisation and health status: evidence from 16 European countries. Age Ageing. 2016 May;45(3):431-5. doi: 10.1093/ageing/afw044. Epub 2016 Mar 24.

    PMID: 27013499BACKGROUND
  • Picco L, Achilla E, Abdin E, Chong SA, Vaingankar JA, McCrone P, Chua HC, Heng D, Magadi H, Ng LL, Prince M, Subramaniam M. Economic burden of multimorbidity among older adults: impact on healthcare and societal costs. BMC Health Serv Res. 2016 May 10;16:173. doi: 10.1186/s12913-016-1421-7.

    PMID: 27160080BACKGROUND
  • Laires PA, Perelman J. The current and projected burden of multimorbidity: a cross-sectional study in a Southern Europe population. Eur J Ageing. 2018 Sep 1;16(2):181-192. doi: 10.1007/s10433-018-0485-0. eCollection 2019 Jun.

    PMID: 31139032BACKGROUND
  • Buja A, Rivera M, De Battisti E, Corti MC, Avossa F, Schievano E, Rigon S, Baldo V, Boccuzzo G, Ebell MH. Multimorbidity and Hospital Admissions in High-Need, High-Cost Elderly Patients. J Aging Health. 2020 Jun/Jul;32(5-6):259-268. doi: 10.1177/0898264318817091. Epub 2018 Dec 6.

    PMID: 30522388BACKGROUND
  • McPhail SM. Multimorbidity in chronic disease: impact on health care resources and costs. Risk Manag Healthc Policy. 2016 Jul 5;9:143-56. doi: 10.2147/RMHP.S97248. eCollection 2016.

    PMID: 27462182BACKGROUND
  • Bahler C, Huber CA, Brungger B, Reich O. Multimorbidity, health care utilization and costs in an elderly community-dwelling population: a claims data based observational study. BMC Health Serv Res. 2015 Jan 22;15:23. doi: 10.1186/s12913-015-0698-2.

    PMID: 25609174BACKGROUND
  • Williams JS, Egede LE. The Association Between Multimorbidity and Quality of Life, Health Status and Functional Disability. Am J Med Sci. 2016 Jul;352(1):45-52. doi: 10.1016/j.amjms.2016.03.004. Epub 2016 Mar 18.

    PMID: 27432034BACKGROUND
  • Gu J, Chao J, Chen W, Xu H, Zhang R, He T, Deng L. Multimorbidity and health-related quality of life among the community-dwelling elderly: A longitudinal study. Arch Gerontol Geriatr. 2018 Jan;74:133-140. doi: 10.1016/j.archger.2017.10.019. Epub 2017 Oct 28.

    PMID: 29096228BACKGROUND
  • Bao XY, Xie YX, Zhang XX, Peng X, Huang JX, Du QF, Wang PX. The association between multimorbidity and health-related quality of life: a cross-sectional survey among community middle-aged and elderly residents in southern China. Health Qual Life Outcomes. 2019 Jun 24;17(1):107. doi: 10.1186/s12955-019-1175-0.

    PMID: 31234889BACKGROUND
  • Makovski TT, Schmitz S, Zeegers MP, Stranges S, van den Akker M. Multimorbidity and quality of life: Systematic literature review and meta-analysis. Ageing Res Rev. 2019 Aug;53:100903. doi: 10.1016/j.arr.2019.04.005. Epub 2019 Apr 30.

    PMID: 31048032BACKGROUND
  • Liu J, Yu W, Zhou J, Yang Y, Chen S, Wu S. Relationship between the Number of Noncommunicable Diseases and Health-Related Quality of Life in Chinese Older Adults: A Cross-Sectional Survey. Int J Environ Res Public Health. 2020 Jul 17;17(14):5150. doi: 10.3390/ijerph17145150.

    PMID: 32708844BACKGROUND
  • Makovski TT, Le Coroller G, Putrik P, Choi YH, Zeegers MP, Stranges S, Ruiz Castell M, Huiart L, van den Akker M. Role of clinical, functional and social factors in the association between multimorbidity and quality of life: Findings from the Survey of Health, Ageing and Retirement in Europe (SHARE). PLoS One. 2020 Oct 20;15(10):e0240024. doi: 10.1371/journal.pone.0240024. eCollection 2020.

    PMID: 33079931BACKGROUND
  • Nunes BP, Flores TR, Mielke GI, Thume E, Facchini LA. Multimorbidity and mortality in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2016 Nov-Dec;67:130-8. doi: 10.1016/j.archger.2016.07.008. Epub 2016 Aug 2.

    PMID: 27500661BACKGROUND
  • Wei MY, Mukamal KJ. Multimorbidity and Mental Health-Related Quality of Life and Risk of Completed Suicide. J Am Geriatr Soc. 2019 Mar;67(3):511-519. doi: 10.1111/jgs.15678. Epub 2018 Nov 24.

    PMID: 30471103BACKGROUND
  • Feng X, Tan X, Riley B, Zheng T, Bias T, Sambamoorthi U. Polypharmacy and Multimorbidity Among Medicaid Enrollees: A Multistate Analysis. Popul Health Manag. 2018 Apr;21(2):123-129. doi: 10.1089/pop.2017.0065. Epub 2017 Jul 6.

    PMID: 28683221BACKGROUND
  • Nguyen TN, Ngangue P, Haggerty J, Bouhali T, Fortin M. Multimorbidity, polypharmacy and primary prevention in community-dwelling adults in Quebec: a cross-sectional study. Fam Pract. 2019 Nov 18;36(6):706-712. doi: 10.1093/fampra/cmz023.

    PMID: 31104072BACKGROUND
  • Vetrano DL, Palmer K, Marengoni A, Marzetti E, Lattanzio F, Roller-Wirnsberger R, Lopez Samaniego L, Rodriguez-Manas L, Bernabei R, Onder G; Joint Action ADVANTAGE WP4 Group. Frailty and Multimorbidity: A Systematic Review and Meta-analysis. J Gerontol A Biol Sci Med Sci. 2019 Apr 23;74(5):659-666. doi: 10.1093/gerona/gly110.

    PMID: 29726918BACKGROUND
  • Hanlon P, Nicholl BI, Jani BD, Lee D, McQueenie R, Mair FS. Frailty and pre-frailty in middle-aged and older adults and its association with multimorbidity and mortality: a prospective analysis of 493 737 UK Biobank participants. Lancet Public Health. 2018 Jul;3(7):e323-e332. doi: 10.1016/S2468-2667(18)30091-4. Epub 2018 Jun 14.

    PMID: 29908859BACKGROUND
  • Kristensen K, Konig HH, Hajek A. The association of multimorbidity, loneliness, social exclusion and network size: findings from the population-based German Ageing Survey. BMC Public Health. 2019 Oct 28;19(1):1383. doi: 10.1186/s12889-019-7741-x.

    PMID: 31660910BACKGROUND
  • Hajek A, Kretzler B, Konig HH. Multimorbidity, Loneliness, and Social Isolation. A Systematic Review. Int J Environ Res Public Health. 2020 Nov 23;17(22):8688. doi: 10.3390/ijerph17228688.

    PMID: 33238506BACKGROUND
  • Kristensen K, Konig HH, Hajek A. The longitudinal association of multimorbidity on loneliness and network size: Findings from a population-based study. Int J Geriatr Psychiatry. 2019 Oct;34(10):1490-1497. doi: 10.1002/gps.5158. Epub 2019 Jun 25.

    PMID: 31172559BACKGROUND
  • Stickley A, Koyanagi A. Physical multimorbidity and loneliness: A population-based study. PLoS One. 2018 Jan 24;13(1):e0191651. doi: 10.1371/journal.pone.0191651. eCollection 2018.

    PMID: 29364978BACKGROUND
  • Kadambi S, Abdallah M, Loh KP. Multimorbidity, Function, and Cognition in Aging. Clin Geriatr Med. 2020 Nov;36(4):569-584. doi: 10.1016/j.cger.2020.06.002. Epub 2020 Aug 16.

    PMID: 33010895BACKGROUND
  • Wang XX, Lin WQ, Chen XJ, Lin YY, Huang LL, Zhang SC, Wang PX. Multimorbidity associated with functional independence among community-dwelling older people: a cross-sectional study in Southern China. Health Qual Life Outcomes. 2017 Apr 17;15(1):73. doi: 10.1186/s12955-017-0635-7.

    PMID: 28412945BACKGROUND
  • Bao J, Chua KC, Prina M, Prince M. Multimorbidity and care dependence in older adults: a longitudinal analysis of findings from the 10/66 study. BMC Public Health. 2019 May 16;19(1):585. doi: 10.1186/s12889-019-6961-4.

    PMID: 31096943BACKGROUND
  • Wang C, Pu R, Li Z, Ji L, Li X, Ghose B, Huang R, Tang S. Subjective health and quality of life among elderly people living with chronic multimorbidity and difficulty in activities of daily living in rural South Africa. Clin Interv Aging. 2019 Jul 17;14:1285-1296. doi: 10.2147/CIA.S205734. eCollection 2019.

    PMID: 31409978BACKGROUND
  • van Gennip IE, Pasman HR, Oosterveld-Vlug MG, Willems DL, Onwuteaka-Philipsen BD. The development of a model of dignity in illness based on qualitative interviews with seriously ill patients. Int J Nurs Stud. 2013 Aug;50(8):1080-9. doi: 10.1016/j.ijnurstu.2012.12.014. Epub 2013 Jan 8.

    PMID: 23312465BACKGROUND
  • Ferretti, F., Pozza, A., Pallassini, M. et al. Gender invariance of dignity in non-terminal elderly patients with chronic diseases: a multicentric study. Qual Quant 53, 1645-1656 (2019). https://doi.org/10.1007/s11135-018-00831-z

    BACKGROUND
  • BLACK, K., & DOBBS, D. (2014). Community-dwelling older adults' perceptions of dignity: core meanings, challenges, supports and opportunities. Ageing and Society, 34(8), 1292-1313.

    BACKGROUND
  • Oosterveld-Vlug MG, Pasman HR, van Gennip IE, Muller MT, Willems DL, Onwuteaka-Philipsen BD. Dignity and the factors that influence it according to nursing home residents: a qualitative interview study. J Adv Nurs. 2014 Jan;70(1):97-106. doi: 10.1111/jan.12171. Epub 2013 May 26.

    PMID: 23711199BACKGROUND
  • Wallace E, Salisbury C, Guthrie B, Lewis C, Fahey T, Smith SM. Managing patients with multimorbidity in primary care. BMJ. 2015 Jan 20;350:h176. doi: 10.1136/bmj.h176. No abstract available.

    PMID: 25646760BACKGROUND
  • Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.

    PMID: 22739426BACKGROUND
  • Doroszkiewicz H, Sierakowska M. Factors associated with risk of care dependency in disabled geriatric patients. Scand J Caring Sci. 2021 Mar;35(1):134-142. doi: 10.1111/scs.12827. Epub 2020 Feb 24.

    PMID: 32091637BACKGROUND
  • Lommi M, Matarese M, Alvaro R, Piredda M, De Marinis MG. The experiences of self-care in community-dwelling older people: a meta-synthesis. Int J Nurs Stud. 2015 Dec;52(12):1854-67. doi: 10.1016/j.ijnurstu.2015.06.012. Epub 2015 Jul 17.

    PMID: 26296653BACKGROUND
  • Lee E, Park E. Self-care behavior and related factors in older patients with uncontrolled hypertension. Contemp Nurse. 2017 Dec;53(6):607-621. doi: 10.1080/10376178.2017.1368401. Epub 2017 Aug 29.

    PMID: 28831843BACKGROUND
  • Borhaninejad V, Shati M, Bhalla D, Iranpour A, Fadayevatan R. A Population-Based Survey to Determine Association of Perceived Social Support and Self-Efficacy With Self-Care Among Elderly With Diabetes Mellitus (Kerman City, Iran). Int J Aging Hum Dev. 2017 Dec;85(4):504-517. doi: 10.1177/0091415016689474. Epub 2017 Jan 24.

    PMID: 28114826BACKGROUND
  • Mendoza-Nunez VM, Flores-Bello C, Correa-Munoz E, Retana-U Galde R, Ruiz-Ramos M. Relationship between social support networks and diabetes control and its impact on the quality of life in older community-dwelling Mexicans. Nutr Hosp. 2016 Nov 29;33(6):1312-1316. doi: 10.20960/nh.776.

    PMID: 28000458BACKGROUND
  • Yang SO, Jeong GH, Kim SJ, Lee SH. Correlates of self-care behaviors among low-income elderly women with hypertension in South Korea. J Obstet Gynecol Neonatal Nurs. 2014 Jan-Feb;43(1):97-106. doi: 10.1111/1552-6909.12265. Epub 2013 Dec 19.

    PMID: 24354464BACKGROUND
  • Buck HG, Dickson VV, Fida R, Riegel B, D'Agostino F, Alvaro R, Vellone E. Predictors of hospitalization and quality of life in heart failure: A model of comorbidity, self-efficacy and self-care. Int J Nurs Stud. 2015 Nov;52(11):1714-22. doi: 10.1016/j.ijnurstu.2015.06.018. Epub 2015 Jul 17.

    PMID: 26234935BACKGROUND
  • Seid MA. Health-related quality of life and extent of self-care practice among heart failure patients in Ethiopia. Health Qual Life Outcomes. 2020 Feb 14;18(1):27. doi: 10.1186/s12955-020-01290-7.

    PMID: 32059670BACKGROUND
  • Lee MK, Oh J. Health-Related Quality of Life in Older Adults: Its Association with Health Literacy, Self-Efficacy, Social Support, and Health-Promoting Behavior. Healthcare (Basel). 2020 Oct 16;8(4):407. doi: 10.3390/healthcare8040407.

    PMID: 33081352BACKGROUND
  • Imaginario C, Rocha M, Machado P, Antunes C, Martins T. Self-care profiles of the elderly institutionalized in Elderly Care Centres. Arch Gerontol Geriatr. 2018 Sep-Oct;78:89-95. doi: 10.1016/j.archger.2018.05.012. Epub 2018 May 31.

    PMID: 29935371BACKGROUND
  • Mlinac ME, Feng MC. Assessment of Activities of Daily Living, Self-Care, and Independence. Arch Clin Neuropsychol. 2016 Sep;31(6):506-16. doi: 10.1093/arclin/acw049. Epub 2016 Jul 29.

    PMID: 27475282BACKGROUND
  • Chan EY, Samsudin SA, Lim YJ. Older patients' perception of engagement in functional self-care during hospitalization: A qualitative study. Geriatr Nurs. 2020 May-Jun;41(3):297-304. doi: 10.1016/j.gerinurse.2019.11.009. Epub 2019 Nov 29.

    PMID: 31787364BACKGROUND
  • Xu X, Mishra GD, Jones M. Evidence on multimorbidity from definition to intervention: An overview of systematic reviews. Ageing Res Rev. 2017 Aug;37:53-68. doi: 10.1016/j.arr.2017.05.003. Epub 2017 May 13.

    PMID: 28511964BACKGROUND
  • Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013 Aug 4;6:61-8. doi: 10.4137/HSI.S11093. eCollection 2013.

    PMID: 25114561BACKGROUND
  • Sasseville M, Chouinard MC, Fortin M. Patient-reported outcomes in multimorbidity intervention research: A scoping review. Int J Nurs Stud. 2018 Jan;77:145-153. doi: 10.1016/j.ijnurstu.2017.09.016. Epub 2017 Sep 29.

    PMID: 29080440BACKGROUND
  • Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167.

    PMID: 23358487BACKGROUND
  • Lee HJ, Lee M, Ha JH, Lee Y, Yun J. Effects of healthcare interventions on psychosocial factors of patients with multimorbidity: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Nov/Dec;91:104241. doi: 10.1016/j.archger.2020.104241. Epub 2020 Aug 25.

    PMID: 32882587BACKGROUND
  • Poitras ME, Maltais ME, Bestard-Denomme L, Stewart M, Fortin M. What are the effective elements in patient-centered and multimorbidity care? A scoping review. BMC Health Serv Res. 2018 Jun 14;18(1):446. doi: 10.1186/s12913-018-3213-8.

    PMID: 29898713BACKGROUND
  • World Health Organization. 2015. World report on aging and health. Available in URL: https://apps.who.int/iris/bitstream/handle/10665/186463/9789240694811_eng.pdf?sequence=1

    BACKGROUND
  • Brettschneider C, Luck T, Fleischer S, Roling G, Beutner K, Luppa M, Behrens J, Riedel-Heller SG, Konig HH. Cost-utility analysis of a preventive home visit program for older adults in Germany. BMC Health Serv Res. 2015 Apr 3;15:141. doi: 10.1186/s12913-015-0817-0.

    PMID: 25884452BACKGROUND
  • Ruiz S, Snyder LP, Rotondo C, Cross-Barnet C, Colligan EM, Giuriceo K. Innovative Home Visit Models Associated With Reductions In Costs, Hospitalizations, And Emergency Department Use. Health Aff (Millwood). 2017 Mar 1;36(3):425-432. doi: 10.1377/hlthaff.2016.1305.

    PMID: 28264943BACKGROUND
  • Tappenden P, Campbell F, Rawdin A, Wong R, Kalita N. The clinical effectiveness and cost-effectiveness of home-based, nurse-led health promotion for older people: a systematic review. Health Technol Assess. 2012;16(20):1-72. doi: 10.3310/hta16200.

    PMID: 22490205BACKGROUND
  • Goehner A, Kricheldorff C, Bitzer EM. Trained volunteers to support chronically ill, multimorbid elderly between hospital and domesticity - a systematic review of one-on-one-intervention types, effects, and underlying training concepts. BMC Geriatr. 2019 May 2;19(1):126. doi: 10.1186/s12877-019-1130-2.

    PMID: 31046693BACKGROUND
  • Knecht JG, Fischer B. Undergraduate Nursing Students' Experience of Service-Learning: A Phenomenological Study. J Nurs Educ. 2015 Jul;54(7):378-84. doi: 10.3928/01484834-20150617-04.

    PMID: 26155029BACKGROUND
  • Davis RL, Beel-Bates C, Jensen S. The Longitudinal Elder Initiative: helping students learn to care for older adults. J Nurs Educ. 2008 Apr;47(4):179-82. doi: 10.3928/01484834-20080401-09.

    PMID: 18468295BACKGROUND
  • Kruger BJ, Roush C, Olinzock BJ, Bloom K. Engaging nursing students in a long-term relationship with a home-base community. J Nurs Educ. 2010 Jan;49(1):10-6. doi: 10.3928/01484834-20090828-07. Epub 2010 Jan 4.

    PMID: 19731887BACKGROUND
  • Conti G, Bowers C, O'Connell MB, Bruer S, Bugdalski-Stutrud C, Smith G, Bickes J, Mendez J. Examining the effects of an experiential interprofessional education activity with older adults. J Interprof Care. 2016;30(2):184-90. doi: 10.3109/13561820.2015.1092428. Epub 2016 Feb 25.

    PMID: 26913632BACKGROUND
  • Walton J, Blossom H. The experience of nursing students visiting older adults living in rural communities. J Prof Nurs. 2013 Jul-Aug;29(4):240-51. doi: 10.1016/j.profnurs.2012.05.010.

    PMID: 23910926BACKGROUND
  • Wheeler EC, Waterhouse JK. Telephone interventions by nursing students: improving outcomes for heart failure patients in the community. J Community Health Nurs. 2006 Fall;23(3):137-46. doi: 10.1207/s15327655jchn2303_1.

    PMID: 16863399BACKGROUND
  • Ng KYY, Leung GYC, Tey AJ, Chaung JQ, Lee SM, Soundararajan A, Yow KS, Ngiam NHW, Lau TC, Wong SF, Wong CH, Koh GC. Bridging the intergenerational gap: the outcomes of a student-initiated, longitudinal, inter-professional, inter-generational home visit program. BMC Med Educ. 2020 May 11;20(1):148. doi: 10.1186/s12909-020-02064-x.

    PMID: 32393249BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • José Manuel Hernández Padilla, PhD

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The type of intervention on which the project is based does not allow for the participants to be masked and they will know to which group they are allocated. However, the team that will collect data (assessors) will not know the group to which each participant is allocated. To ensure assessor masking, participants will be instructed to never reveal the group to which they have been assigned and assessors will be instructed to never ask the participants to which group they have been assigned. The assessors will not participate in the recruitment process, the supervision of nursing students' home-visits, nor the data analysis process. The group to which the participants have been allocated will be numerically coded (not labelled) in the database and the researchers in charge of data analysis will not know which numerical code refers to the intervention group and which code refers to the control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Older adults who meet the inclusion criteria and voluntarily accept to participate in this study will be randomly allocated to one of two arms: intervention group (arm 1) or control group (arm 2). Participants from both arms will be assessed at the same time for data collection purposes (pre-test, post-test and 6-month follow-up) and they will be exposed to the experimental condition (intervention group) or the control condition (control group) at the same time for 12-weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Profesor Titular)

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 3, 2022

Study Start

March 15, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

All IPD will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party (j.hernandez-padilla@ual.es)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Two years (24 months) after the study completion.
Access Criteria
The PI must be contacted and a minimum number of co-authors from the research team must be included in any publication

Locations