- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02843022
Effectiveness of a Web-based Nursing Intervention in the Reduction of Postpartum Depression and Parenting Stress.
19 april 2018 uppdaterad av: Saint Anselm College
Enhancing Follow-up Mechanisms for Women at Risk for Postpartum Depression
The purpose of the study is to determine whether a web-based nursing intervention delivered during the postpartum period will decrease symptoms of postpartum depression and parenting stress.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
The purpose of this randomized, controlled trial is to determine whether receiving standardized messages (text or email) from a postpartum nurse four times/week for 6 months after delivery will decrease symptoms of postpartum depression and parenting stress.
Enrolled women will be randomized to one of three groups.
The first group will receive the usual care, which is a phone call from a nurse within the first few weeks postpartum.
The second group will receive four standardized messages each week, the content of which will include infant care, maternal self-care and inspirational material.
The third group will receive the same four standardized messages each week, and in addition, two of these weekly messages will offer the option to respond with a request for a nurse to call them.
Baseline data will be collected during the postpartum hospitalization, and follow-up will occur by email at 3 weeks, 3 months and 6 months postpartum.
Studietyp
Interventionell
Inskrivning (Faktisk)
683
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New Hampshire
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Manchester, New Hampshire, Förenta staterna, 03102
- Catholic Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Able to speak and read English
- Access to a device which can receive text or email messages
Exclusion Criteria:
- Non-English speaking,
- No access to a device which can receive text or email messages
- Age younger than 18 -
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Usual care
Participant will receive the usual care provided by the nursing staff at Catholic Medical Center.
A lactation consultant or childbirth educator attempts to call each patient within 2-3 weeks prior to discharge.
Only one call is made, and a message left if the patient would like to call back.
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Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge.
Message left if patient is not reached.
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Experimentell: Message Only
Participant will receive the usual care, and in addition, will receive four standardized electronic messages weekly for six months postpartum.
These will be one-way messages without the option to respond.
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Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge.
Message left if patient is not reached.
supportive and educational short messages
Andra namn:
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Experimentell: Message and Nurse
Participant will receive the usual care as well as the four standardized electronic messages/week for 6 months.
Two of these weekly messages will be two-way, providing the option for the participant to respond "yes" to an offer to have a nurse call them.
A nurse phone call if requested will be provided with a week.
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Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge.
Message left if patient is not reached.
supportive and educational short messages
Andra namn:
If participant responds "yes" to an offer for a phone call, a nurse calls them within a week of this response
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
postpartum depression symptoms
Tidsram: 6 months postpartum
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Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points
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6 months postpartum
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
breastfeeding outcomes
Tidsram: 6 months postpartum
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Duration and pattern of infant feeding
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6 months postpartum
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patient satisfaction/experience
Tidsram: 6 months postpartum
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Participant response to the experience of receiving messages and having the option to talk to a nurse (group 3), as well as their sense of connection to the hospital where they gave birth
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6 months postpartum
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Parenting stress
Tidsram: 6 months postpartum
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Scores on the Parenting Stress Index (PSI-4)
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6 months postpartum
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Deborah E. McCarter, PhD, RN, Saint Anselm College
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- McCarter-Spaulding D, Shea S. Effectiveness of Discharge Education on Postpartum Depression. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):168-72. doi: 10.1097/NMC.0000000000000236.
- Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
- Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.
- Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Lewinsohn P. Web-Based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program. JMIR Res Protoc. 2012 Nov 22;1(2):e18. doi: 10.2196/resprot.2329.
- Segre LS, O'Hara MW, Arndt S, Stuart S. The prevalence of postpartum depression: the relative significance of three social status indices. Soc Psychiatry Psychiatr Epidemiol. 2007 Apr;42(4):316-21. doi: 10.1007/s00127-007-0168-1. Epub 2007 Feb 13.
- Paulson JF, Dauber S, Leiferman JA. Individual and combined effects of postpartum depression in mothers and fathers on parenting behavior. Pediatrics. 2006 Aug;118(2):659-68. doi: 10.1542/peds.2005-2948.
- Aguilera A, Munoz RF. Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Prof Psychol Res Pr. 2011 Dec 1;42(6):472-478. doi: 10.1037/a0025499.
- Aguilera A, Berridge C. Qualitative feedback from a text messaging intervention for depression: benefits, drawbacks, and cultural differences. JMIR Mhealth Uhealth. 2014 Nov 5;2(4):e46. doi: 10.2196/mhealth.3660.
- Segre LS, O'Hara MW, Arndt S, Beck CT. Screening and counseling for postpartum depression by nurses: the women's views. MCN Am J Matern Child Nurs. 2010 Sep-Oct;35(5):280-5. doi: 10.1097/NMC.0b013e3181e62679.
- Piette JD, Schillinger D. Applying interactive health technologies for vulnerable populations. In: King TE, Wheeler MB, eds. Medical management of vulnerable and underserved patients: Principles, practice and populations. New York: McGraw-Hill; 2007.
- Mood and Anxiety Disorders in Pregnant and Postpartum Women. J Obstet Gynecol Neonatal Nurs. 2015 Sep-Oct;44(5):687-9. doi: 10.1111/1552-6909.12734. Epub 2015 Jun 30. No abstract available.
- Earls MF; Committee on Psychosocial Aspects of Child and Family Health American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010 Nov;126(5):1032-9. doi: 10.1542/peds.2010-2348. Epub 2010 Oct 25.
- Knitzer J, Theberge S, Johnson K. Reducing maternal depression and its impact on young children: Toward a responsive early childhood policy framework. Project Thrive 2008.
- McLennan JD, Kotelchuck M. Parental prevention practices for young children in the context of maternal depression. Pediatrics. 2000 May;105(5):1090-5. doi: 10.1542/peds.105.5.1090.
- Sills MR, Shetterly S, Xu S, Magid D, Kempe A. Association between parental depression and children's health care use. Pediatrics. 2007 Apr;119(4):e829-36. doi: 10.1542/peds.2006-2399.
- Beck A, Crain AL, Solberg LI, Unutzer J, Glasgow RE, Maciosek MV, Whitebird R. Severity of depression and magnitude of productivity loss. Ann Fam Med. 2011 Jul-Aug;9(4):305-11. doi: 10.1370/afm.1260.
- Brealey SD, Hewitt C, Green JM, Morrell J, Gilbody S. Screening for postnatal depression -- is it acceptable to women and healthcare professionals? A systematic review and meta-synthesis. Journal of Reproductive & Infant Psychology. 2010;28:328-344.
- Gjerdingen DK, Yawn BP. Postpartum depression screening: importance, methods, barriers, and recommendations for practice. J Am Board Fam Med. 2007 May-Jun;20(3):280-8. doi: 10.3122/jabfm.2007.03.060171.
- Furber G, Jones GM, Healey D, Bidargaddi N. A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. J Med Internet Res. 2014 Oct 8;16(10):e219. doi: 10.2196/jmir.3096.
- Le HN, Perry DF, Sheng X. Using the internet to screen for postpartum depression. Matern Child Health J. 2009 Mar;13(2):213-21. doi: 10.1007/s10995-008-0322-8. Epub 2008 Feb 16.
- Drake E, Howard E, Kinsey E. Online screening and referral for postpartum depression: an exploratory study. Community Ment Health J. 2014 Apr;50(3):305-11. doi: 10.1007/s10597-012-9573-3. Epub 2013 Jan 3.
- Leung SS, Leung C, Lam TH, Hung SF, Chan R, Yeung T, Miao M, Cheng S, Leung SH, Lau A, Lee DT. Outcome of a postnatal depression screening programme using the Edinburgh Postnatal Depression Scale: a randomized controlled trial. J Public Health (Oxf). 2011 Jun;33(2):292-301. doi: 10.1093/pubmed/fdq075. Epub 2010 Sep 29.
- Sword W, Busser D, Ganann R, McMillan T, Swinton M. Women's care-seeking experiences after referral for postpartum depression. Qual Health Res. 2008 Sep;18(9):1161-73. doi: 10.1177/1049732308321736.
- Senti J, LeMire SD. Patient satisfaction with birthing center nursing care and factors associated with likelihood to recommend institution. J Nurs Care Qual. 2011 Apr-Jun;26(2):178-85. doi: 10.1097/NCQ.0b013e3181fe93e6.
- McCarter DE, Demidenko E, Sisco TS, Hegel MT. Technology-assisted nursing for postpartum support: A randomized controlled trial. J Adv Nurs. 2019 Oct;75(10):2223-2235. doi: 10.1111/jan.14114. Epub 2019 Jul 21.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2015
Primärt slutförande (Faktisk)
1 februari 2018
Avslutad studie (Faktisk)
1 februari 2018
Studieregistreringsdatum
Först inskickad
20 juli 2016
Först inskickad som uppfyllde QC-kriterierna
20 juli 2016
Första postat (Uppskatta)
25 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NURS2015-3
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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