- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07782905
Talk2gether Program for Social Connection in Older Adults
19. august 2026 opdateret af: Jason Burnett, The University of Texas Health Science Center, Houston
Talk2gether Program
The purpose of this study is to see if it is feasible to recruit and retain older adults in a, weekly phone call program delivered through the Harris County Precinct 2 Healthcare and Social Services Team and to see how participation in the program affect older adults' loneliness, social isolation, psychological well-being, and satisfaction, and what barriers or challenges arise during implementation
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jason Burnett, PhD
- Telefonnummer: (713) 873-4685
- E-mail: Jason.Burnett@uth.tmc.edu
Undersøgelse Kontakt Backup
- Navn: Jordan Broussard
- Telefonnummer: 713 500 0321
- E-mail: Jordan.Broussard@uth.tmc.edu
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas Health Science Center at Houston
-
Kontakt:
- Jason Burnett, PhD
- Telefonnummer: 713-873-4685
- E-mail: Jason.Burnett@uth.tmc.edu
-
Kontakt:
- Jordan Broussard
- Telefonnummer: (713) 500-0321
- E-mail: Jordan.Broussard@uth.tmc.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- able to provide informed consent
- able to speaks English or Spanish
- able to hear sufficiently using the telephone
Exclusion Criteria:
- Need for another person to consent on the participant's behalf
- suspected or confirmed decision-making capacity impairments
- uncontrolled psychiatric illnesses such as schizophrenia, paranoia, delusion, or delirium
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Talk2gether program
|
Participants will be paired with a trained team member.
The team member will then initiate contact with the older adult(s) to begin 90 days of weekly social calls.
These weekly social calls will be mostly unstructured, but supported by resource and conversation guides.
At the end of 90 days, if the older adult wishes to continue to receive calls, that request will be accommodated
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Program Feasibility as assessed by number of participants recruited
Tidsramme: end of intervention (90 days after baseline)
|
end of intervention (90 days after baseline)
|
|
|
Program Feasibility as assessed by number of participants that adhered to the weekly calls
Tidsramme: end of intervention (90 days after baseline)
|
end of intervention (90 days after baseline)
|
|
|
Feasibility as assessed by number of participants that completed the program
Tidsramme: end of intervention (90 days after baseline)
|
end of intervention (90 days after baseline)
|
|
|
Feasibility as assessed by number of participants that encountered barriers or challenges as assessed by the Client Satisfaction Questionnaire (CSQ-8)
Tidsramme: end of intervention (90 days after baseline)
|
This is an 8 item questionnaire and Items 2, 4, 5, and 8 are reverse scored.
Total scores range from 8 to 32, with the higher number indicating greater satisfaction
|
end of intervention (90 days after baseline)
|
|
Feasibility as assessed by number of participants that encountered barriers or challenges as reported on the Caller and Older Adult feedback form
Tidsramme: end of intervention (90 days after baseline)
|
end of intervention (90 days after baseline)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in social connectedness as assessed by the Lubben Social Network Scale-6
Tidsramme: baseline, post-intervention (Day 90)
|
This is a 6-item self-report measure assessing perceived social support and social network size from family and friends.
Each item is scored from 0 to 5, and total scores range from 0 to 30.
Higher scores indicate greater social connectedness and lower risk of social isolation
|
baseline, post-intervention (Day 90)
|
|
Change in loneliness as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation scale
Tidsramme: Baseline, end of intervention (90 days)
|
This is an 8 item scale.
Each item is rated on a 5-point scale from 1(never) to 5 ( always).
Raw scores range from 8 to 40 and are converted to PROMIS T-scores, with a mean of 50 and standard deviation of 10 in the reference population.
Higher scores indicate greater perceived social isolation/loneliness.
|
Baseline, end of intervention (90 days)
|
|
Change in depressive symptoms as assessed by the Patient Health Questionnaire-2
Tidsramme: Baseline, end of intervention (90 days)
|
This is a 2-item self-report measure .
Each item is scored from 0 (not at all) to 3 (nearly every day).
Total scores range from 0 to 6, with higher scores indicating greater depressive symptom burden.
|
Baseline, end of intervention (90 days)
|
|
Change in signs of elder mistreatment as assessed by the Elder Mistreatment Screening and Response Tool (EM-SART).
Tidsramme: Baseline, end of intervention (90 days)
|
This is a 3 item questionnaire and each will be scored as either 1(yes) or 0(no) for a maximum score of 3. Higher scores or more endorsed concerns indicate a greater number of signs suggestive of elder mistreatment
|
Baseline, end of intervention (90 days)
|
|
Change in sense of purpose using the 7-item Ryff Purpose in Life Scale.
Tidsramme: Baseline, end of intervention (90 days)
|
This is a 7 item questionnaire and each item is rated on a Likert-type scale, commonly from 1(strongly disagree) to 6( strongly agree).
Negatively worded items are reverse scored, and item scores are summed to generate a total score.
Total scores range from 7 to 42, with higher scores indicating a greater sense of purpose in life.
|
Baseline, end of intervention (90 days)
|
|
Client satisfaction as assessed by the Client Satisfaction Questionnaire
Tidsramme: end of intervention (90 days)
|
This is an 8 item questionnaire.
Scores are summed across items once.
Items 2, 4, 5, and 8 are reverse scored.
Total scores range from 8 to 32, with the higher number indicating greater satisfaction
|
end of intervention (90 days)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jason Burnett, PhD, The University of Texas Health Science Center, Houston
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
3. august 2026
Primær færdiggørelse (Anslået)
3. august 2028
Studieafslutning (Anslået)
3. august 2028
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
24. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSC-MS-26-0434
Plan for individuelle deltagerdata (IPD)
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