- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07576855
Effect of a Telephone Reminiscence Intervention on Mental Health (TRIM)
Strengthening Bonds: A Telephone Reminiscence Intervention to Reduce Social Isolation and Improve Mental Health in Rural Older Adults
The goal of this study is to learn whether a telephone-based program that helps people share life memories can reduce loneliness and improve mental well-being, life satisfaction, and social support in older adults and their caregivers living in rural areas.
This study has two parts. In the first part, researchers will gather feedback from a small group of older adults and informal caregivers to see if the updated telephone reminiscence program works well and is easy to use.
In the second part, researchers will test the telephone reminiscence program in a clinical trial study to see whether the updated telephone reminiscence program reduces loneliness and improves social support, life satisfaction, and mental well-being in older adults and their caregivers. The researchers will also examine how the program impacts how often and for what reason you reminisce.
The main questions this study aims to answer are:
- Does the telephone reminiscence program improve social support, life satisfaction, and mental well-being and reduce loneliness in rural older adults and their caregivers? How does the telephone reminiscence impact how often and for what reason participants reminisce?
- How often and how long do participants use the program?
- How satisfied are older adults and informal caregivers with the program? In this study researchers will compare participants who begin the telephone reminiscence program right away with participants who start the program after a 12-week waiting period to see whether starting the program earlier leads to better outcomes.
Participants will:
- Take part in telephone calls 3 times a week that invite older adults to talk about their life experiences.
- Answer brief survey questions about social support, loneliness, and mental well-being, and life satisfaction over time.
- Include both older adults and their informal caregivers, who may also participate by recording questions in their own voice.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Detailed Description This study evaluates a telephone based reminiscence program designed to reduce social isolation and improve mental health among older adults living in rural areas, while also engaging informal caregivers who support them. The study consists of two sequential parts: an initial development and refinement phase, followed by a randomized wait list controlled clinical trial.
Study Overview and Rationale Older adults living in rural areas experience high levels of social isolation and limited access to supportive services due to geographic distance, transportation barriers, and reduced availability of technology based resources. Many older adults in rural communities rely on landline telephones and do not have consistent access to broadband internet, creating barriers to participation in digital health interventions. Telephone based programs that do not require internet access may offer a low burden, scalable approach to supporting mental well being and social connection in these populations.
Reminiscence based interventions encourage individuals to reflect on meaningful life experiences and share personal stories. Prior research suggests that reminiscence can support emotional well being, reinforce identity, and promote a sense of connection. This study builds on previous work evaluating a telephone reminiscence program and extends it by improving accessibility for rural users and formally testing its effectiveness over a longer intervention period.
Part 1: Program Refinement and Feasibility Assessment The first part of the study focuses on refining and enhancing the telephone reminiscence program to improve accessibility, usability, and acceptability for rural older adults and informal caregivers. A total of 16 older adult-caregiver dyads will participate in short term (four week) use of the enhanced program and provide feedback through structured discussions and surveys.
Data collected in this phase inform refinements to the program's functionality, including ease of interaction using landline telephones, clarity of prompts, and caregiver involvement features (such as the ability for caregivers to record questions in their own voice). Findings from Part 1 are used to finalize the version of the program evaluated in the clinical trial phase.
Part 2: Randomized Wait List Controlled Clinical Trial The second part of the study is a randomized, parallel group, wait list controlled clinical trial designed to evaluate the effects of the telephone reminiscence program on social and mental health outcomes in a larger sample of rural older adults and their informal caregivers. A total of 170 older adult-informal caregiver dyads will be enrolled in this phase of the study.
After completion of baseline assessments, eligible participants are randomly assigned to one of two groups:
- An immediate intervention group (85 dyads), which begins the telephone reminiscence program right away
- A wait list group (85 dyads), which begins the same program after a 12 week waiting period All participants eventually receive access to the intervention. The comparison between groups during the initial 12 week period allows evaluation of whether earlier participation in the program leads to improvements in social support, loneliness, and mental well being.
Intervention Description The telephone reminiscence program consists of automated phone calls delivered up to three times per week over a 12 week period. During each call, older adult participants are invited to respond to simple, meaningful questions about their life experiences and memories. Participants may choose how much or how little they wish to share during each call, and calls can be ended at any time.
Informal caregivers associated with participating older adults may also take part by recording personalized questions or prompts in their own voice, enabling a sense of connection and engagement between calls. The intervention does not require internet access, smartphones, or computer use.
Study Outcomes and Assessments Outcome assessments are conducted at baseline and at follow up time points aligned with the intervention and wait list periods. Primary outcomes focus on changes in social support, loneliness, and mental well being among older adults. Secondary outcomes include adherence to the program, frequency and duration of use, and changes in reminiscence patterns. Satisfaction with the program is assessed for both older adults and informal caregivers.
Sample Size and Statistical Considerations The sample size of 170 dyads in the randomized trial phase is based on power calculations informed by prior studies of the telephone reminiscence program and is sufficient to detect moderate differences in primary social and mental health outcomes between the immediate intervention and wait list groups. Statistical analyses will compare changes in outcomes between groups during the first 12 weeks, with additional analyses examining within participant changes over time and associations between program engagement and outcomes.
Ethical Considerations This study is considered minimal risk. All participants eventually receive access to the intervention, and participation is voluntary. The wait list design allows evaluation of intervention effects while ensuring equitable access to the program.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Juliette Shellman, PhD, RN
- Telefonní číslo: 860-341-1177
- E-mail: lifestory@uconn.edu
Studijní místa
-
-
Connecticut
-
Storrs, Connecticut, Spojené státy, 06269
- University of Connecticut
-
Kontakt:
- Juliette Shellman, PhD, RN
- Telefonní číslo: 860-341-1177
- E-mail: juliette.shellman@uconn.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Older adults aged 60 years or older living in a rural area.
- Able to read and speak English.
- Living in a rural area as defined by the U.S. Census Bureau.
- Has an informal caregiver (family member, partner, friend, or neighbor) willing to participate, or is an informal caregiver of an eligible older adult.
- Able to participate in telephone-based activities.
Exclusion Criteria:
- Significant hearing impairment that would interfere with telephone participation.
- Cognitive impairment as indicated by three or more errors on a brief cognitive screening assessment.
- Participation in the program development phase of this study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Immediate Telephone Reminiscence Program
Participants assigned to this arm will begin the 12-week telephone-based reminiscence program immediately after baseline assessment.
Older adults will receive automated telephone calls up to three times per week that invite them to respond to meaningful questions about their life experiences.
Informal caregivers associated with participating older adults may also participate by recording personalized questions in their own voice.
Participants will complete outcome assessments at baseline and at follow-up time points during and after the intervention period.
|
The telephone reminiscence program is a 12-week behavioral intervention designed to support social connection and mental well-being among older adults living in rural areas.
The program consists of automated telephone calls delivered up to three times per week that invite older adult participants to respond to simple, meaningful questions about their life experiences and memories.
Participants may share as much or as little as they wish during each call and may end the call at any time.
Informal caregivers associated with participating older adults may also take part by recording personalized questions or prompts in their own voice.
The program does not require internet access, smartphones, or computer use.
|
|
Žádný zásah: Wait-List Control (Delayed Telephone Reminiscence Program)
Participants assigned to this arm will not receive the telephone-based reminiscence program during the initial 12-week period following baseline assessment.
Participants in this wait-list control arm will complete the same outcome assessments as the immediate intervention group.
After the 12-week waiting period, participants will begin the same 12-week telephone reminiscence program.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mental Well-Being
Časové okno: Baseline, 12 weeks, and 24 weeks
|
The Mental Health Continuum Short Form (MHC-SF) will be used to assess mental health and well-being.
The 14 item scale measures emotional, social, and psychological dimensions of mental health.
Participants answer each item on a 6-point scale, ranging from 0 and 5, resulting in a total score between 0 to 70.
The emotional well-being subscale has a range from 0 to 15, the social well-being subscale scores range from 0 to 25, and the psychological well-being subscale scores range from 0 to 30.
Higher scores on MHC- SF indicate a higher level of mental well-being.
The MHC-SF has demonstrated excellent internal consistency (>.80) and discriminant validity in adults in the United States, and its test-retest reliability has also been demonstrated, with an average of 0.68 over three consecutive three-month periods and 0.65 over a 9-month period.
|
Baseline, 12 weeks, and 24 weeks
|
|
Social Support
Časové okno: Baseline, 12 weeks, and 24 weeks
|
Social support will be measured using 11-item Duke Social Support Index (DSSI), designed to provide a quick and reliable assessment of social support among older adults.
This scale evaluates social support across two domains, including social interactions and subjective support.
The total score of the scale ranges from 11 to 33.
A higher score indicates more social support.
The 11-item DSSI demonstrates strong reliability and validity.
The scale's internal consistency is reflected in a Cronbach's alpha of 0.77 for elderly populations and its Test-retest reliability scores range from 0.70 to 0.81.
|
Baseline, 12 weeks, and 24 weeks
|
|
Loneliness
Časové okno: Baseline, 12 weeks, and 24 weeks
|
Loneliness will be measured UCLA 3 Item Loneliness Scale is a brief 3-item scale that measures three dimensions of loneliness: relational connectedness, social connectedness, and self.
Responses are provided on a 3-point (response scale ranging from "hardly" to "often", with total scores ranging from 3 to 9. The instrument has favorable psychometric properties, including high internal consistency (ranging from 0.89 to 0.94) and a good test-retest reliability over one year (r = 0.73).
|
Baseline, 12 weeks, and 24 weeks
|
|
Life satisfaction
Časové okno: Baseline, 12, 24 weeks
|
Life satisfaction will be measured using the Satisfaction with Life Scale, which assesses overall cognitive judgments of one's life satisfaction.
Higher scores indicate greater life satisfaction.
|
Baseline, 12, 24 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Program Adherence
Časové okno: During the 12-week intervention period
|
Program adherence will be assessed by the proportion of scheduled telephone calls completed by participants during the intervention period.
|
During the 12-week intervention period
|
|
Frequency and Duration of Program Use
Časové okno: During the 12-week intervention period
|
Frequency and duration of use will be assessed by the number of telephone reminiscence calls completed per week and the duration of each call during the intervention period.
|
During the 12-week intervention period
|
|
Reminiscence Functions
Časové okno: Baseline, 12, 24 weeks
|
Reminiscence Functions will be assessed using the Modified Reminiscence Functions Scale (MRFS), a 29-item questionnaire that measures how often people use different types of reminiscence.
The scale captures multiple reminiscence functions, including self-regard, death preparation, bitterness revival, conversation, intimacy maintenance, teaching and informing, and boredom reduction.
Participants rate how often they engage in each type of reminiscence on a 5-point scale ranging from never to very often.
Higher scores indicate more frequent use of a specific reminiscence function.
The MRFS has demonstrated good reliability, with strong internal consistency across subscales.
|
Baseline, 12, 24 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
- Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741.
- Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.
- Shellman JM, Zhang D. Psychometric testing of the Modified Reminiscence Functions Scale. J Nurs Meas. 2014;22(3):500-10. doi: 10.1891/1061-3749.22.3.500.
- Valtorta NK, Kanaan M, Gilbody S, Ronzi S, Hanratty B. Loneliness and social isolation as risk factors for coronary heart disease and stroke: systematic review and meta-analysis of longitudinal observational studies. Heart. 2016 Jul 1;102(13):1009-16. doi: 10.1136/heartjnl-2015-308790. Epub 2016 Apr 18.
- Keyes CL. Mental health in adolescence: is America's youth flourishing? Am J Orthopsychiatry. 2006 Jul;76(3):395-402. doi: 10.1037/0002-9432.76.3.395.
- Gale CR, Westbury L, Cooper C. Social isolation and loneliness as risk factors for the progression of frailty: the English Longitudinal Study of Ageing. Age Ageing. 2018 May 1;47(3):392-397. doi: 10.1093/ageing/afx188.
- National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Community-Based Solutions to Promote Health Equity in the United States; Baciu A, Negussie Y, Geller A, Weinstein JN, editors. Communities in Action: Pathways to Health Equity. Washington (DC): National Academies Press (US); 2017 Jan 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK425848/
- O'Rourke N, Cappeliez P, Claxton A. Functions of reminiscence and the psychological well-being of young-old and older adults over time. Aging Ment Health. 2011 Mar;15(2):272-81. doi: 10.1080/13607861003713281. Epub 2010 Dec 6.
- Cappeliez P, O'Rourke N. Empirical validation of a model of reminiscence and health in later life. J Gerontol B Psychol Sci Soc Sci. 2006 Jul;61(4):P237-44. doi: 10.1093/geronb/61.4.p237.
- Washington G. Modification and psychometric testing of the Reminiscence Functions Scale. J Nurs Meas. 2009;17(2):134-47. doi: 10.1891/1061-3749.17.2.134.
- Goodger B, Byles J, Higganbotham N, Mishra G. Assessment of a short scale to measure social support among older people. Aust N Z J Public Health. 1999 Jun;23(3):260-5. doi: 10.1111/j.1467-842x.1999.tb01253.x.
- Krueger RA, Casey MA. Focus Groups: A Practical Guide for Applied Research. third. Sage Publications, Inc; 2000.
- The US Census Bureau. Urban and Rural. https://www.census.gov/programs- surveys/geography/guidance/geo-areas/urban-rural.html. Published 2023.
- Krippendorff K. Content Analysis: An Introduction to Its Methodology. Fourth Edi. SAGE Publications, Inc.; 2019. doi:10.4135/9781071878781
- Yang, Y., Toussaint, B., Harbaran, S., Likamora, E., Graham, C., & Shellman, J. (2024). Analysis of the Impact of a Telephone Reminiscence Program on Mental Health for Community-Dwelling Older Adults: A Mixed- Methods Study [Poster Presentation]. ICLIP 2024 Virtual Conference " Keeping our Legacy Alive: Honoring the Past and Embracing the Future".
- Golaszewski NM, LaCroix AZ, Godino JG, Allison MA, Manson JE, King JJ, Weitlauf JC, Bea JW, Garcia L, Kroenke CH, Saquib N, Cannell B, Nguyen S, Bellettiere J. Evaluation of Social Isolation, Loneliness, and Cardiovascular Disease Among Older Women in the US. JAMA Netw Open. 2022 Feb 1;5(2):e2146461. doi: 10.1001/jamanetworkopen.2021.46461.
- Lee HY, Kanthawala S, Choi EY, Kim YS. Rural and non-rural digital divide persists in older adults: Internet access, usage, and attitudes toward technology. Gerontechnology. 2021;20(2):1-9. doi:10.4017/gt.2021.20.2.32-472.12
- United States Government Accountability Office. Broadband National Strategy Needed to Guide Federal Efforts to Reduce Digital Divide. 2022.
- National Healthcare Quality and Disparities Report: Chartbook on Healthcare for Veterans [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Nov. Report No.: 21-0003. Available from http://www.ncbi.nlm.nih.gov/books/NBK578546/
- Cohen SA, Greaney ML. Aging in Rural Communities. Curr Epidemiol Rep. 2023;10(1):1-16. doi: 10.1007/s40471-022-00313-9. Epub 2022 Nov 9.
- Henning-Smith C, Moscovice I, Kozhimannil K. Differences in Social Isolation and Its Relationship to Health by Rurality. J Rural Health. 2019 Sep;35(4):540-549. doi: 10.1111/jrh.12344. Epub 2019 Jan 4.
- James W, Cossman JS. Long-Term Trends in Black and White Mortality in the Rural United States: Evidence of a Race-Specific Rural Mortality Penalty. J Rural Health. 2017 Jan;33(1):21-31. doi: 10.1111/jrh.12181. Epub 2016 Apr 8.
- Cossman J, James W, Wolf JK. The differential effects of rural health care access on race-specific mortality. SSM Popul Health. 2017 Jul 29;3:618-623. doi: 10.1016/j.ssmph.2017.07.013. eCollection 2017 Dec.
- Older Adults Technology Services. Aging Connected: Exposing the Hidden Connectivity Crisis for Older Adults. 2022. https://oats.org/aging-connected-exposing-the-hidden-connectivity-crisis- for-older-adults/
- Cohen SA, Nash CC, Byrne EN, Mitchell LE, Greaney ML. Black/White Disparities in Obesity Widen with Increasing Rurality: Evidence from a National Survey. Health Equity. 2022 Mar 3;6(1):178-188. doi: 10.1089/heq.2021.0149. eCollection 2022.
- Agency for Healthcare Research and Quality. National Healthcare Quality and Disparities Report: Chartbook on Healthcare for Veterans. Rockville, MD; 2020. https://www.ncbi.nlm.nih.gov/books/NBK578553/#
- Cohen SA, Ahmed N, Brown MJ, Meucci MR, Greaney ML. Rural-urban differences in informal caregiving and health-related quality of life. J Rural Health. 2022 Mar;38(2):442-456. doi: 10.1111/jrh.12581. Epub 2021 May 6.
- Smith AS, Trevelyan E. The Older Population in Rural America: 2012-2016. Washington, DC; 2018.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-311-910 / B2025-0454
- 1R44AG097382-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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